6 November 2026 · Updated November 2026 · 17 min read

Peptides and TRT Together: What the Controlled Trials, Monitoring and Rules Show

Peptides and TRT together: four human studies gave GH or hCG with testosterone. What they monitored, and where sermorelin, BPC-157 and CJC-1295 stand in 2026.

PeptidesTestosteroneTRTGrowth Hormone SecretagogueshCGHormone Optimization503A CompoundingFDA RegulationPractitioner Guides
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Cited sources

Peptides and TRT have been studied together in a small number of controlled trials, and all of them paired testosterone with recombinant growth hormone, a licensed biologic, or with hCG; none used a compounded peptide [8, 23, 24]. Blackman and colleagues randomized 74 older men in a 2 x 2 factorial design and reported that lean body mass rose 1.4 kg on testosterone alone, 3.1 kg on growth hormone alone and 4.3 kg on the two together over 26 weeks [23]. Sattler and colleagues randomized 122 men to transdermal testosterone with or without GH for 16 weeks and recorded a mean systolic blood pressure rise of 12 mm Hg in every group [24].

A prescriber asked to add a peptide to a testosterone program can start from those trials, the newer axis studies, the laboratory monitoring each one used, and the regulatory status of each component a clinic might combine, all set out below with a table of the pairings people search for. Patients preparing for that conversation will find the same record. ExaVeyra writes as a supplier, and combination decisions are the prescriber’s.

4
human studies located that gave GH or hCG with testosterone: two randomized trials, one physiology study in 12 hypopituitary men and one retrospective series, each read below
8
laboratory and clinical endpoints in the monitoring table, each tied to the Endocrine Society guideline or to a named trial
31 Dec 2026
end date of the DEA telemedicine flexibilities that cover remote prescribing of Schedule III testosterone

Regulatory status

Testosterone is an FDA-approved drug for men with low testosterone and an associated medical condition, and a Schedule III controlled substance; the DEA telemedicine flexibilities for prescribing it remotely run through 31 December 2026 [16, 17]. Sermorelin is compounded under section 503A, with the qualifying route confirmed by the pharmacy [19, 22]. BPC-157, CJC-1295 and ipamorelin have no approved product; BPC-157 is one of six peptides named in the HHS draft enforcement discretion policy of 30 October 2026, which is interim until rulemaking and not binding, while CJC-1295 and ipamorelin remain outside it [18, 20]. Hormone optimization formulations and sermorelin are compounded by our 503A pharmacy partner against a patient-specific prescription; where a controlled substance such as testosterone is prescribed, our 503A pharmacy partner dispenses it under its own DEA registration; non-catalog peptides such as BPC-157 are offered for IND-authorized clinical trials through our pharmacy partner. Whether any two of these belong in the same chart is the prescriber’s decision.

Testosterone and the growth hormone axis interact in both directions

Testosterone and the growth hormone axis interact in both directions. Gibney and colleagues showed in 12 hypopituitary men that the IGF-1 rise produced by GH was augmented by testosterone, that testosterone alone did not raise IGF-1, and that the two had independent and additive effects on protein metabolism [25]. The combination trials of the 2000s were built on that physiology [23, 24].

Dias and colleagues then showed the mechanism in older men with low testosterone. Thirty-seven men randomized to transdermal testosterone, an aromatase inhibitor or placebo were followed for 12 months, and testosterone increased GH pulse frequency while the IGF-1 rise at 6 months depended on aromatization to estradiol [6]. A testosterone program therefore shifts the GH axis before any secretagogue is added [6].

Route matters as well. Weissberger and colleagues reported in postmenopausal women that oral estrogen raised 24-hour GH secretion while lowering IGF-1, and transdermal estradiol raised IGF-1 without changing GH [27]. A prescriber who reads an IGF-1 value on a patient taking a sex steroid is reading a number the steroid and its route have already moved [27].

Published trials report additive body-composition effects and measurable adverse signals

The 2002 JAMA trial is the reference. Blackman and colleagues randomized 57 women and 74 men aged 65 to 88 to GH, sex steroid, both or placebo for 26 weeks, and in men lean body mass rose 0.1 kg on placebo, 1.4 kg on testosterone, 3.1 kg on GH and 4.3 kg on the combination, with fat mass falling in the GH groups [23]. Strength rose only marginally, by 13.5 kg with the combination, and adverse effects were a prespecified outcome [23].

Sattler and colleagues reported the same direction in 2009. Across six dose groups of transdermal testosterone with or without GH, lean mass rose 1.0 to 3.0 kg and fat fell 0.4 to 2.3 kg over 16 weeks, and composite strength rose in the three highest groups [24]. Systolic and diastolic blood pressure rose by a mean of 12 and 8 mm Hg in every group, and the authors described the other adverse events as modest and reversible [24].

Both trials used recombinant GH, a licensed biologic. The only located human series of compounded secretagogues in hypogonadal men is the 2017 chart review by Sigalos and colleagues, in which 14 of 105 records met inclusion and the outcome was serum IGF-1 without a control group [13].

The combination literature is real, small and built on recombinant GH. Reading it as evidence for a compounded secretagogue added to testosterone requires a step the trials did not take.

Monitoring in the trials tracked hematocrit, blood pressure, IGF-1 and prostate markers

Each trial carried a safety panel, and the Endocrine Society guideline turns that panel into a plan: evaluate symptoms, adverse effects and adherence, measure serum testosterone and hematocrit, and evaluate prostate cancer risk during the first year [1]. The guideline also lists an elevated hematocrit and a PSA above 4 ng/mL among the reasons not to start [1].

Hematocrit leads the list because erythrocytosis is the adverse effect the testosterone literature documents best, with short-acting injectable formulations carrying the highest incidence [4]. The TRAVERSE anemia substudy showed the other side of the same effect: anemia remitted in 41.0 percent of men on testosterone versus 27.5 percent on placebo at 6 months [3].

When a GH-axis agent is added, IGF-1 and blood pressure join the panel. Sattler 2009 recorded the blood pressure rise in every group, Dias 2017 measured IGF-1 at 3 and 6 months, and Blackman 2002 tracked adverse effects as a main outcome [6, 23, 24]. TRAVERSE adds atrial fibrillation, acute kidney injury and pulmonary embolism as events that occurred more often on testosterone over a mean of 33 months [2].

Laboratory or clinical endpointWhere it comes fromWhy it belongs on a combined protocol
Fasting morning total testosterone, repeatedEndocrine Society guideline diagnostic criteria; harmonized range 264 to 916 ng/dL in young nonobese menConfirms the diagnosis before any component is added [1, 5]
Hematocrit (and hemoglobin)Guideline monitoring plan; erythrocytosis review; TRAVERSE anemia substudyThe best documented adverse effect of testosterone [1, 3, 4]
PSA and prostate assessmentGuideline monitoring plan and contraindicationsProstate cancer risk is evaluated in the first year [1]
IGF-1Dias 2017 at 3 and 6 months; Sigalos 2017 as the only outcomeThe surrogate every GH-axis agent is judged by, already shifted by testosterone and estradiol [6, 13, 27]
Blood pressureSattler 2009 (12 and 8 mm Hg rise); FDA 2025 labeling changeBoth components raise it; FDA added a blood pressure warning to testosterone labels [16, 24]
Glucose and metabolic markersBlackman 2002 adverse effect outcomes; Sattler 2009 safety testsGH raises glucose; the factorial trial counted it among adverse effects [23, 24]
Cardiovascular eventsTRAVERSE primary and secondary endpointsNoninferior for the composite; more atrial fibrillation, acute kidney injury and pulmonary embolism [2]
Semen parameters and LH/FSHHsieh 2013; Hochu 2025 reviewExogenous testosterone suppresses the gonadal axis; hCG is the studied counter-measure [7, 8]

Each searched pairing leaves a specific evidence gap

The searches that bring people to this page pair testosterone with compounds the controlled literature has never combined with it. The gaps below are specific, and each is a question a trial could answer.

  • No randomized trial has combined sermorelin, CJC-1295 or ipamorelin with testosterone; the Blackman and Sattler trials used recombinant GH, and the Sigalos series measured IGF-1 in 14 men without a control group [13, 23, 24].
  • No human study of BPC-157 with testosterone exists; Mendias and Awan concluded in 2026 that rigorous human safety data for the unapproved peptides are scarce, and FDA states it has no, or only limited, safety information for BPC-157 by the proposed routes [15, 18].
  • Sinha and colleagues wrote in 2020 that a paucity of data on the clinical effects of growth hormone secretagogues limits understanding of their role alongside androgen therapy [14].
  • The hCG and TRT evidence is a retrospective series of 26 men followed for a mean of 6.2 months, plus a 10-day experimental model; no randomized fertility-outcome trial of the pairing has been published [8, 26].
  • The kisspeptin trials gave kisspeptin-54 by intravenous infusion under a research protocol to 32 women and 32 men; they say nothing about a compounded kisspeptin-10 product, which FDA lists in category 2 [9, 10, 18].
  • TRAVERSE enrolled men at cardiovascular risk on testosterone gel; whether its event rates apply to injectable formulations, to younger men, or to men also taking a GH-axis agent was not tested [2].
  • Dominikowski 2026 reported no long-term safety data for the compounded secretagogues, so the duration question that the 26-week and 16-week trials leave open has no answer for those compounds [12].

hCG and kisspeptin act on the gonadal axis that exogenous testosterone suppresses

The pairing with the most physiological logic is hCG. Exogenous testosterone suppresses LH and FSH, and intratesticular testosterone and spermatogenesis fall with them, which is why the Endocrine Society recommends against starting testosterone in men planning fertility in the near term [1, 7]. Roth and colleagues showed in 37 men with experimentally induced gonadotropin deficiency that very low hCG levels raised intratesticular testosterone in a dose-dependent way [26].

Hsieh and colleagues reviewed 26 hypogonadal men, mean age 35.9, on injectable or transdermal testosterone with concomitant hCG. Semen parameters did not change over more than a year of follow-up, no patient became azoospermic, and nine of 26 contributed to a pregnancy [8]. Hochu and colleagues reviewed that literature in 2025 and placed hCG, short-acting testosterone forms and enclomiphene among the fertility-preserving options [7].

Kisspeptin sits one step higher. Skorupskaite and colleagues describe it as the upstream signal to GnRH neurons that controls pulsatile gonadotropin release and mediates sex-steroid feedback [11]. The randomized crossover trials by Thurston and Mills gave intravenous kisspeptin-54 under research protocols and reported changes in sexual brain processing in women and men, a setting far from a compounded kisspeptin-10 preparation, which FDA placed in category 2 on 29 September 2023 [9, 10, 18].

Each component carries a distinct regulatory status

Testosterone is approved solely for men who lack or have low testosterone in conjunction with an associated medical condition, and FDA’s February 2025 class-wide labeling change added the TRAVERSE results, removed the boxed cardiovascular language, kept the limitation of use for age-related hypogonadism and added a blood pressure warning [16]. It is listed by name among the Schedule III anabolic steroids, approved labeling carries the CIII designation, and the DEA and HHS fourth temporary extension keeps the telemedicine flexibilities for controlled medications in force through 31 December 2026 [17].

Sermorelin was the active ingredient of Geref, an approved product now listed as discontinued, and a 503A pharmacy may compound with a bulk substance that is a component of an FDA-approved drug, complies with a USP or NF monograph, or appears on the 503A bulks list [19, 22]. Sermorelin has no entry on FDA’s safety-risk tables, and the pharmacy states the route it relies on in writing [18, 19].

BPC-157 and CJC-1295 sit in the nominated-but-withdrawn table, ipamorelin acetate in the category 2 table with FDA’s record of serious adverse events including death by the intravenous route [18]. On 30 October 2026 HHS published a draft enforcement discretion policy covering six peptides, BPC-157 among them, under which it does not intend to take enforcement action against a state-licensed pharmacy or licensed physician compounding with them while the bulks list is developed through rulemaking; the notice states the draft is not binding on HHS or the public, and CJC-1295, ipamorelin and sermorelin are outside it [20]. The Pharmacy Compounding Advisory Committee had discussed BPC-157 and six other peptides on 23 and 24 July 2026, and its advice is not binding [21].

Commonly searched pairings compared against the published record

The table below places each pairing people search for beside the strongest human evidence located for it and the regulatory status of the peptide component. A pairing with no row of human data is a pairing the prescriber is designing without a precedent, which is a fact to record in the chart, whatever the prescriber decides.

Searched pairingStrongest human evidence locatedPeptide component status (4 November 2026)
Recombinant GH and testosteroneBlackman 2002 (74 men, RCT, 26 weeks); Sattler 2009 (122 men, RCT, 16 weeks); Gibney 2005 (12 men) [23, 24, 25]Licensed biologic; outside 503A compounding
Sermorelin and TRTNo combined trial; Sigalos 2017 secretagogue series in 14 hypogonadal men, IGF-1 only [13]Compounded under 503A against a prescription; route confirmed by the pharmacy [19, 22]
CJC-1295 or ipamorelin and TRTNo human study of the combination; reviews describe a paucity of data [12, 14]Withdrawn nomination (CJC-1295); category 2 (ipamorelin, 503B); outside the HHS policy [18, 20]
BPC-157 and TRTNo human study; rigorous safety data scarce [15]Withdrawn nomination; named in the HHS draft enforcement discretion policy of 30 October 2026; offered for IND-authorized trials through our pharmacy partner [18, 20]
hCG and TRTHsieh 2013 (26 men, retrospective); Roth 2010 (37 men, 10-day model) [8, 26]Licensed biologic since 23 March 2020, outside 503A compounding; prescribed by the practitioner [28]
Kisspeptin and TRTNo combined study; Thurston 2022 and Mills 2023 gave kisspeptin-54 intravenously under research protocols [9, 10]Kisspeptin-10 in category 2 since 29 September 2023 [18]

Documenting a combined program from the supply side

A combined program is three supply chains and one chart. Testosterone, where a controlled substance is prescribed, is dispensed by our 503A pharmacy partner under its own DEA registration, with the prescription drug monitoring and recordkeeping obligations that Schedule III carries [17]. Sermorelin and the hormone optimization formulations are compounded by our 503A pharmacy partner against a patient-specific prescription [19].

  • The diagnosis record: two fasting morning total testosterone values and the symptoms that justify the first component [1, 5].
  • The baseline panel the guideline and the trials used: hematocrit, PSA where indicated, blood pressure, IGF-1 if a GH-axis agent is planned, and glucose [1, 6, 24].
  • The written 503A route for sermorelin from the pharmacy, and the lot number and beyond-use date from each label [19, 22].
  • For any non-catalog peptide, the sponsor’s IND number, sponsor details and protocol, confirmed before any supply; the HHS draft policy changes enforcement intent for six peptides and leaves their unapproved status unchanged [20].
  • The telemedicine basis for a controlled-substance prescription, which rests on the DEA extension through 31 December 2026 and on state rules that are often stricter [17].
  • Adverse events with the lot number, reported to the dispensing pharmacy and to FDA through MedWatch.

Building combined programs on verified supply and complete records

Practices that run testosterone on guideline-grade diagnosis and monitoring, add a GH-axis agent only with IGF-1 and blood pressure on the panel, and record the regulatory basis of every component are building on the strongest part of this literature. A verified ExaVeyra account connects a practice with a 503A pharmacy partner licensed in 33 jurisdictions including Puerto Rico, confirms formulary availability for the practice’s state, and supplies the COA and characterization records on request.

Anyone may ask the scientific team a question or apply without an NPI, and NPI verification, which takes 1 to 3 business days, gives access to the practitioner portal, product documentation and pricing. The combination trials of the 2000s set a high bar for measurement, and a practice that meets it today is well placed as the secretagogue literature catches up.

Educational Disclaimer: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.

References

  1. 1.Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. PMID 29562364. doi:10.1210/jc.2018-00229Clinical practice guideline from a 10-member task force using the GRADE approach and two commissioned systematic reviews. Carries in this article: diagnosis on symptoms plus repeated fasting morning total testosterone, the recommendation against starting testosterone in men planning fertility in the near term, the contraindications that include elevated hematocrit and a PSA above 4 ng/mL, and the standardized monitoring plan of symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year. Funded by the Endocrine Society; author disclosures are listed in the publication.
  2. 2.Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. PMID 37326322. doi:10.1056/NEJMoa2215025Multicenter randomized, double-blind, placebo-controlled noninferiority trial (TRAVERSE); 5,246 men aged 45 to 80 with hypogonadal symptoms, two fasting testosterone values below 300 ng/dL and existing or high cardiovascular risk; mean follow-up 33 months. Carries in this article: a primary cardiovascular event in 7.0 percent of the testosterone group and 7.3 percent of placebo (hazard ratio 0.96), with more atrial fibrillation, acute kidney injury and pulmonary embolism on testosterone. Funded by a consortium of manufacturers led by AbbVie.
  3. 3.Pencina KM, Travison TG, Artz AS, Lincoff AM, Nissen SE, Flevaris P, et al. Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(10):e2340030. PMID 37889486. PMC10611996. doi:10.1001/jamanetworkopen.2023.40030Randomized placebo-controlled trial nested in TRAVERSE at 316 US sites; 5,204 men, 815 with anemia at baseline. Carries in this article: the trial reported anemia remitting in 41.0 percent of men on testosterone versus 27.5 percent on placebo at 6 months, which is the hemoglobin side of the hematocrit story and the reason both values are tracked. Funded by the same manufacturer consortium as TRAVERSE.
  4. 4.Ohlander SJ, Varghese B, Pastuszak AW. Erythrocytosis Following Testosterone Therapy. Sex Med Rev. 2018;6(1):77-85. PMID 28526632. PMC5690890. doi:10.1016/j.sxmr.2017.04.001Literature review. Carries in this article: the risk of erythrocytosis on testosterone compared with controls is well established, short-acting injectable formulations carry the highest incidence, and the thromboembolic consequence remains unclear, which is why hematocrit is the first laboratory value every combination protocol tracks.
  5. 5.Travison TG, Vesper HW, Orwoll E, Wu F, Kaufman JM, Wang Y, et al. Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the United States and Europe. J Clin Endocrinol Metab. 2017;102(4):1161-1173. PMID 28324103. PMC5460736. doi:10.1210/jc.2016-2935Cross-calibration study of 9,054 community-dwelling men in four cohorts against a CDC reference method. Carries in this article: the harmonized 2.5th to 97.5th percentile range of 264 to 916 ng/dL for total testosterone in healthy nonobese men aged 19 to 39, which is the reference the guideline’s diagnostic threshold rests on.
  6. 6.Dias JP, Veldhuis JD, Carlson O, Shardell M, Chia CW, Melvin D, et al. Effects of transdermal testosterone gel or an aromatase inhibitor on serum concentration and pulsatility of growth hormone in older men with age-related low testosterone. Metabolism. 2017;69:143-147. PMID 28285644. PMC5950718. doi:10.1016/j.metabol.2017.01.025Randomized controlled proof-of-concept trial at the National Institute on Aging; 37 men aged 65 or older with total testosterone below 350 ng/dL, randomized to transdermal testosterone, an aromatase inhibitor or placebo for 12 months, with GH pulsatility measured by deconvolution at baseline and 3 months and IGF-1 at 3 and 6 months. Carries in this article: testosterone increased GH pulse frequency, and the IGF-1 rise at 6 months depended on aromatization to estradiol. The authors declared no conflicts.
  7. 7.Hochu G, Geyer-Kim I, Kim E. Preserving spermatogenesis in testosterone deficiency: innovations in replacement and stimulatory therapies. Transl Androl Urol. 2025;14(12):3975-3987. PMID 41522318. PMC12779434. doi:10.21037/tau-2025-480Narrative review from an academic urology group updating the authors’ 2013 publication. Carries in this article: exogenous testosterone suppresses LH and FSH and impairs spermatogenesis; concomitant low-dose hCG sustains intratesticular testosterone and sperm production even with full gonadotropin suppression; enclomiphene stimulates the axis directly. Disclosures listed in the publication.
  8. 8.Hsieh TC, Pastuszak AW, Hwang K, Lipshultz LI. Concomitant intramuscular human chorionic gonadotropin preserves spermatogenesis in men undergoing testosterone replacement therapy. J Urol. 2013;189(2):647-650. PMID 23260550. doi:10.1016/j.juro.2012.09.043Retrospective record review at an academic andrology center; 26 hypogonadal men, mean age 35.9 years, mean follow-up 6.2 months, on injectable or transdermal testosterone with concomitant hCG. Carries in this article: semen parameters did not change over more than a year of follow-up, no patient became azoospermic, and nine of 26 contributed to a pregnancy, which is the clinical series most often cited for the hCG and TRT pairing.
  9. 9.Thurston L, Hunjan T, Ertl N, Wall MB, Mills EG, Suladze S, et al. Effects of Kisspeptin Administration in Women With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2022;5(10):e2236131. PMID 36287566. PMC9606846. doi:10.1001/jamanetworkopen.2022.36131Double-masked, placebo-controlled two-way crossover randomized trial at a UK university center; 40 premenopausal women randomized, 32 completed both visits. Carries in this article: an intravenous kisspeptin-54 infusion under a research protocol modulated sexual and attraction brain processing on functional imaging, which is the setting in which kisspeptin has human data, as distinct from a compounded kisspeptin-10 product. Investigator disclosures are listed in the publication.
  10. 10.Mills EG, Ertl N, Wall MB, Thurston L, Yang L, Suladze S, et al. Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023;6(2):e2254313. PMID 36735255. PMC9898824. doi:10.1001/jamanetworkopen.2022.54313Double-blind, placebo-controlled two-way crossover randomized trial at a UK academic center; 37 men randomized, 32 completed. Carries in this article: kisspeptin modulated brain activity in the sexual-processing network and increased penile tumescence by up to 56 percent over placebo, under an intravenous research protocol. Two investigators reported consulting fees from Myovant Sciences and one was employed by a contract imaging organization.
  11. 11.Skorupskaite K, George JT, Anderson RA. The kisspeptin-GnRH pathway in human reproductive health and disease. Hum Reprod Update. 2014;20(4):485-500. PMID 24615662. PMC4063702. doi:10.1093/humupd/dmu009Systematic literature review of human studies to January 2014. Carries in this article: kisspeptin acts upstream of GnRH and signals directly to GnRH neurons to control pulsatile gonadotropin secretion, and it mediates the sex-steroid feedback through which exogenous testosterone suppresses the axis.
  12. 12.Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, Ruchała M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. PMID 42395176. PMC13322892. doi:10.3389/fendo.2026.1822475Narrative review from an academic endocrinology department, read in full text. Carries in this article: sermorelin as the GHRH(1-29) analog that raises the pituitary’s own pulsatile GH output, the absence of long-term safety data for the compounded secretagogues, and tesamorelin as the approved analog with regulatory-grade randomized trials. The authors declared no commercial conflicts.
  13. 13.Sigalos JT, Pastuszak AW, Allison A, Ohlander SJ, Herati A, Lindgren MC, et al. Growth Hormone Secretagogue Treatment in Hypogonadal Men Raises Serum Insulin-Like Growth Factor-1 Levels. Am J Mens Health. 2017;11(6):1752-1757. PMID 28830317. PMC5675260. doi:10.1177/1557988317718662Retrospective chart review at an academic men’s health center; 105 records reviewed, 14 hypogonadal men met inclusion, all on a combined secretagogue regimen, measured by serum IGF-1 without a control group. Carries in this article: the only located human series of compounded secretagogues in hypogonadal men, and the fact that it reports a surrogate marker. The authors declared no conflicts.
  14. 14.Sinha DK, Balasubramanian A, Tatem AJ, Rivera-Mirabal J, Yu J, Kovac J, et al. Beyond the androgen receptor: the role of growth hormone secretagogues in the modern management of body composition in hypogonadal males. Transl Androl Urol. 2020;9(Suppl 2):S149-S159. PMID 32257855. PMC7108996. doi:10.21037/tau.2019.11.30Narrative review of sermorelin, GHRP-2, GHRP-6, ibutamoren and ipamorelin in the hypogonadal setting. Carries in this article: the authors’ statement that a paucity of data on the clinical effects of these compounds limits understanding of their role alongside androgen therapy. Two authors reported advisory or speaking roles with pharmaceutical companies.
  15. 15.Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. PMID 41966639. doi:10.1007/s40279-026-02437-0Narrative review of twelve peptides marketed direct to patients, BPC-157 and sermorelin among them. Carries in this article: the authors’ conclusion that rigorous human safety data for the unapproved peptides are scarce, which is the state of the evidence for the BPC-157 and TRT pairing. One author reported consulting fees from Arthrex for unrelated work.
  16. 16.U.S. Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. Drug Alerts and Statements, 28 February 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-class-wide-labeling-changes-testosterone-products. Verified 4 November 2026.Agency statement, read 4 November 2026. Carries in this article: testosterone is approved solely for men who lack or have low testosterone in conjunction with an associated medical condition; FDA is adding TRAVERSE to all testosterone labels, removing the boxed cardiovascular language, retaining the limitation-of-use language for age-related hypogonadism, and adding a blood pressure warning following ambulatory blood pressure studies.
  17. 17.Controlled substance status and telemedicine prescribing of testosterone, verified 4 November 2026: 21 CFR 1308.13(f)(84), Schedule III anabolic steroids, https://www.ecfr.gov/current/title-21/chapter-II/part-1308/section-1308.13; FDA-approved labeling for testosterone cypionate injection, USP CIII, https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf; Drug Enforcement Administration and Department of Health and Human Services, Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 90 FR 61301 (31 December 2025), effective 1 January 2026 through 31 December 2026, https://www.federalregister.gov/documents/2025/12/31/2025-24123/fourth-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlledThree federal records read together on 4 November 2026. Carries in this article: testosterone is listed by name among the Schedule III anabolic steroids, approved testosterone labeling carries the CIII designation, and the DEA and HHS fourth temporary extension keeps the telemedicine flexibilities for prescribing controlled medications in force through 31 December 2026, after which prescribers rely on whatever rule DEA has published.
  18. 18.U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 22 April 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks. Verified 4 November 2026.Agency web page with the category 2 table and the nominated-but-withdrawn table, read 4 November 2026. Carries in this article: kisspeptin-10 (503A, added 29 September 2023) and ipamorelin acetate (503B) in the category 2 table, BPC-157 and CJC-1295 in the nominated-but-withdrawn table, FDA’s record of serious adverse events including death when ipamorelin was given intravenously in a published study, and its statement that it has no, or only limited, safety information for BPC-157 and kisspeptin-10 by the proposed routes. Sermorelin has no entry.
  19. 19.U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Content current as of 14 May 2026. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act. Verified 4 November 2026.Agency web page, read 4 November 2026. Carries in this article: the three routes by which a bulk substance qualifies for 503A compounding (an applicable USP or NF monograph, a component of an FDA-approved drug, or the 503A bulks list), the route sermorelin is assessed under and the test the compounded secretagogues on the category 2 tables do not meet.
  20. 20.U.S. Department of Health and Human Services. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability. 91 FR 68526-68527 (30 October 2026). Docket HHS-OASH-2026-0496. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances. Verified 4 November 2026.Federal Register notice, full text read through the Federal Register API on 4 November 2026. Carries in this article: HHS announced a draft policy under which it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician compounding with a peptide bulk substance listed in the policy’s Appendix A while the 503A bulks list is developed through rulemaking; the notice restates that compounded drugs are not FDA-approved, says HHS may revisit the interim policy if a safety signal or quality issue arises, and states that the draft establishes no rights and is not binding on HHS or the public. The policy covers six peptides (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500) with conditions and route limits; CJC-1295, ipamorelin and sermorelin are outside it.
  21. 21.U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Content current as of 6 August 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026. Verified 4 November 2026.Agency meeting page, read 4 November 2026. Carries in this article: the committee met on 23 and 24 July 2026 to discuss BPC-157, KPV, TB-500 and MOTS-c on the first day and three further peptides on the second as candidates for the 503A bulks list, with FDA briefing documents posted; committee advice is not binding and the list itself changes only by rulemaking.
  22. 22.U.S. Food and Drug Administration. Drugs@FDA record for NDA 019863, GEREF (sermorelin acetate), EMD Serono: marketing status Discontinued, with the Federal Register determination that the product was not withdrawn for safety or effectiveness reasons. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863. Verified 4 November 2026.Agency database record, read 4 November 2026. Carries in this article: sermorelin was the active ingredient of an approved product that is now discontinued, which is the basis on which a 503A pharmacy assesses the component route and states it in writing.
  23. 23.Blackman MR, Sorkin JD, Münzer T, Bellantoni MF, Busby-Whitehead J, Stevens TE, et al. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. JAMA. 2002;288(18):2282-2292. PMID 12425705. doi:10.1001/jama.288.18.2282Randomized, double-blind, placebo-controlled 2 x 2 factorial trial over 26 weeks; 57 women and 74 men aged 65 to 88, with recombinant GH and sex steroid (testosterone enanthate in men) alone and together. Carries in this article: in men lean body mass rose 0.1 kg on placebo, 1.4 kg on testosterone, 3.1 kg on GH and 4.3 kg on GH plus testosterone, strength rose only marginally with the combination, and adverse effects were tracked as a main outcome. Funded by the National Institute on Aging.
  24. 24.Sattler FR, Castaneda-Sceppa C, Binder EF, Schroeder ET, Wang Y, Bhasin S, et al. Testosterone and growth hormone improve body composition and muscle performance in older men. J Clin Endocrinol Metab. 2009;94(6):1991-2001. PMID 19293261. PMC2690426. doi:10.1210/jc.2008-2338Randomized trial of 122 community-dwelling men, mean age 70.8, with testosterone at or below 550 ng/dL and IGF-1 in the lower adult tertile, assigned to transdermal testosterone with or without recombinant GH for 16 weeks across six groups. Carries in this article: lean mass rose 1.0 to 3.0 kg and fat fell 0.4 to 2.3 kg by dose level, systolic and diastolic blood pressure rose by a mean of 12 and 8 mm Hg in every group, and safety tests were part of the protocol. NIH funded.
  25. 25.Gibney J, Wolthers T, Johannsson G, Umpleby AM, Ho KK. Growth hormone and testosterone interact positively to enhance protein and energy metabolism in hypopituitary men. Am J Physiol Endocrinol Metab. 2005;289(2):E266-E271. PMID 15727949. doi:10.1152/ajpendo.00483.2004Metabolic study in 12 hypopituitary men comparing GH alone, testosterone alone and the two together. Carries in this article: the GH-induced rise in IGF-1 was augmented by testosterone, testosterone alone did not raise IGF-1, and the two had independent and additive effects on protein metabolism, which is the physiological basis for pairing a GH-axis agent with testosterone.
  26. 26.Roth MY, Page ST, Lin K, Anawalt BD, Matsumoto AM, Snyder CN, et al. Dose-dependent increase in intratesticular testosterone by very low-dose human chorionic gonadotropin in normal men with experimental gonadotropin deficiency. J Clin Endocrinol Metab. 2010;95(8):3806-3813. PMID 20484472. PMC2913032. doi:10.1210/jc.2010-0360Randomized study in 37 normal men with gonadotropin deficiency induced by a GnRH antagonist, assigned to one of four low hCG levels or testosterone gel for 10 days, with testicular fluid sampled. Carries in this article: intratesticular testosterone rose with hCG in a dose-dependent manner, and the testosterone gel arm is the model of what exogenous testosterone alone does to the testis.
  27. 27.Weissberger AJ, Ho KK, Lazarus L. Contrasting effects of oral and transdermal routes of estrogen replacement therapy on 24-hour growth hormone (GH) secretion, insulin-like growth factor I, and GH-binding protein in postmenopausal women. J Clin Endocrinol Metab. 1991;72(2):374-381. PMID 1991807. doi:10.1210/jcem-72-2-374Physiological study in postmenopausal women comparing oral and transdermal estrogen. Carries in this article: oral estrogen raised 24-hour GH secretion while lowering IGF-1, and transdermal estradiol raised IGF-1 without changing GH, so the route of a sex steroid changes the IGF-1 value a prescriber later reads when a secretagogue is added.
  28. 28.U.S. Food and Drug Administration. Notice to Compounders: Changes that affect compounding as of March 23, 2020. Content current as of 5 March 2020. https://www.fda.gov/drugs/human-drug-compounding/notice-compounders-changes-affect-compounding-march-23-2020. Verified 5 November 2026.Agency notice read 5 November 2026. Carries in this article: on 23 March 2020 biological products approved under the FD&C Act, human chorionic gonadotropin among the four the notice names, were deemed licensed under the PHS Act and from that date are not eligible for the compounding exemptions in sections 503A and 503B.

Frequently Asked Questions

Can you take peptides with testosterone?
The controlled trials that combined a GH-axis agent with testosterone used recombinant GH, in 74 and 122 older men, and tracked lean mass, blood pressure and adverse effects [23, 24]. No randomized trial has combined a compounded secretagogue or BPC-157 with testosterone, so the decision rests with the prescriber and on the monitoring those trials used [13, 15].
Can sermorelin and TRT be used together?
No trial has tested the pairing. The physiology is documented: testosterone increases GH pulse frequency and raises IGF-1 through aromatization to estradiol, so a secretagogue is added to an axis testosterone has already shifted [6]. Sermorelin is compounded under 503A against a patient-specific prescription, and the pairing is the prescriber’s decision [19, 22].
What does the research say about BPC-157 and TRT?
Nothing directly, because no human study of the combination exists. Mendias and Awan concluded in 2026 that rigorous human safety data for the unapproved peptides are scarce, and FDA states it has no, or only limited, safety information for BPC-157 [15, 18]. The HHS draft enforcement discretion policy of 30 October 2026 names BPC-157 but leaves it unapproved [20].
What do the studies report about hCG with TRT?
Hochu and colleagues reviewed how exogenous testosterone suppresses LH and FSH, with intratesticular testosterone and sperm production falling with them [7]. In a retrospective series of 26 men on testosterone with concomitant hCG, Hsieh and colleagues reported that semen parameters did not change during follow-up and no patient became azoospermic [8]. hCG has been a licensed biologic since 23 March 2020, outside 503A compounding [28], and the Endocrine Society recommends against starting testosterone in men planning fertility in the near term [1].
What peptides go with hormone therapy?
The published pairings are recombinant GH with testosterone in two randomized trials and hCG with testosterone in a retrospective series [8, 23, 24]. Compounded secretagogues, BPC-157 and kisspeptin-10 have no combination data, and reviews from 2020 and 2026 describe a paucity of evidence for them [12, 14, 15]. Which, if any, to add is the prescriber’s decision.
What is hormone optimization with peptides?
The phrase usually describes a testosterone or estradiol program with a GH-axis secretagogue added. The controlled evidence for the idea comes from trials of recombinant GH with testosterone that measured lean mass, strength, blood pressure and adverse effects in older men [23, 24]. The compounded secretagogues have a 14-man retrospective series measuring IGF-1 [13].
What labs are monitored when peptides and TRT are combined?
The Endocrine Society plan measures symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year [1]. The combination trials added blood pressure, which rose a mean of 12 mm Hg systolic in Sattler 2009, IGF-1 at 3 and 6 months in Dias 2017, and adverse effects including glucose in Blackman 2002 [6, 23, 24].
Is testosterone a controlled substance when prescribed with peptides?
Yes. Testosterone is listed by name among the Schedule III anabolic steroids at 21 CFR 1308.13, and approved labeling carries the CIII designation regardless of what else is prescribed [17]. The DEA and HHS telemedicine flexibilities for controlled medications run through 31 December 2026, and state rules on remote prescribing are often stricter [17].
Does TRT raise IGF-1 on its own?
In older men with low testosterone, transdermal testosterone increased GH pulse frequency and raised IGF-1 at 6 months, with the IGF-1 rise depending on aromatization to estradiol [6]. In hypopituitary men testosterone alone did not raise IGF-1 but augmented the rise produced by GH [25]. The baseline IGF-1 therefore depends on what the patient already takes.
Are CJC-1295 and ipamorelin covered by the new HHS peptide policy?
No. The HHS draft enforcement discretion policy of 30 October 2026 covers six peptides (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500), is interim until rulemaking and is stated to be not binding [20]. CJC-1295 sits in FDA’s withdrawn-nomination table and ipamorelin acetate in the category 2 table, and neither has a qualifying 503A route [18, 19].

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