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Kisspeptin-10 research

What published studies found for Kisspeptin-10: 10 papers, 8 in humans, with sample sizes and key results, plus 22 registered clinical trials.

B
Some human evidence
Why: Small single-blind placebo-controlled and crossover physiology studies (about 15 people) show LH and testosterone rises; no trials of clinical outcomes.

Kisspeptin-10 is a research tool, not an approved drug: small human physiology studies show it reliably raises LH (and in men testosterone) for hours, and a 2026 single-blind placebo-controlled study kept gonadotropins elevated for 12 days with intermittent infusions. There are no trials of clinical outcomes such as fertility or symptoms, and it is on the WADA prohibited list. Added small human studies in men (n = 3 to 12) confirm LH and testosterone rises, including in men with type 2 diabetes, and suggest partial attenuation during 24-hour continuous infusion.

✓ 6 positive~ 4 mixed

The kisspeptin-10 study abstracts report hormone responses but no adverse-event data; longer-term human safety is unstudied.

US compounding: Not compoundable (FDA safety list). Still on FDA's 503A Category 2 list (added September 29, 2023) for potential immunogenicity and limited safety data: it can't be compounded. Status for every peptide.

Browse and filter these papersKisspeptin-10 prices and vendors

Registered clinical trials

22 trials of Kisspeptin-10 on ClinicalTrials.gov: 5 active, 13 completed, 5 with posted results. Registered trials include ones that haven't published yet.

TrialStatusPhasePeopleSponsor
Functional Proteins in Polycystic Ovary SyndromeNCT06793098 · started 2025-01-20Recruiting–100Jagiellonian University
Reproductive Hormones During Sustained Administration of KisspeptinNCT02081924 · started 2014-04-02Recruiting–76Imperial College London
Kisspeptin to Quantify GnRH Neuronal Function in Health and DiseaseNCT07224490 · started 2026-03-10RecruitingPhase 140Stephanie B. Seminara, MD
Kisspeptin Administration Subcutaneously to Patients With IHHNCT05896293 · started 2023-02-03RecruitingPhase 236Stephanie B. Seminara, MD
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic AmenorrheaNCT07224438 · started 2025-12-09RecruitingPhase 220Stephanie B. Seminara, MD
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) TreatmentNCT01667406 · started 2012-06-01 · results postedCompletedPhase 2175Imperial College London
Administration of Kisspeptin in Patients With HyperprolactinemiaNCT02956447 · started 2017-11-17 · results postedCompletedPhase 236Massachusetts General Hospital
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic HypogonadismNCT04648969 · started 2019-05-03 · results postedCompletedPhase 218Stephanie B. Seminara, MD
Recall by Genotype: Neuropeptide StimulationNCT05901467 · started 2023-10-20 · results postedTerminatedPhase 116Stephanie B. Seminara, MD
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance TestNCT04958109 · started 2021-10-28 · results postedCompletedPhase 116Massachusetts General Hospital
Kisspeptin Administration in the AdultNCT00914823 · started 2009-06-23CompletedPhase 1256Massachusetts General Hospital
Elucidating Kisspeptin Physiology by Blocking Kisspeptin SignalingNCT01438073 · started 2011-09CompletedPhase 196Massachusetts General Hospital

All 22 Kisspeptin-10 trials, with countries and recruiting status

Human studies

✓ Positivehuman RCTEur J Endocrinol · 2026

Chronic subcutaneous kisspeptin-10 stimulates gonadotropin secretion for 12 days in healthy men.

n = 15 humansRandomized, single-blinded, placebo-controlled study of subcutaneous kisspeptin-10: acute dose-response, 5-day continuous, 12-day intermittent (8 h on, 16 h off)Up to 12 days

15 healthy men (12 controls), single-blind placebo-controlled: subcutaneous kisspeptin-10 dose-dependently raised LH, FSH and testosterone; with continuous 5-day infusion gonadotropins returned to vehicle levels (testosterone stayed raised), while daily 8-hour infusions sustained LH rises for 12 days.

Key resultDaily 8 h infusions over 12 days sustained gonadotropin rises (mean LH increase: vehicle -0.16 ± 0.19; day 1 +1.68 ± 0.25; day 12 +1.14 ± 0.33, P = .003 vs vehicle); continuous 5-day infusion did not sustain gonadotropins
Studied
Healthy men
Compared with
Vehicle
Main outcome
LH, FSH and testosterone
Sample
15 healthy men (study 1: 7, study 2: 4, study 3: 7); 12 men served as controls
Authors' conclusion
Chronic subcutaneous kisspeptin-10 sustains gonadotropin and testosterone secretion in healthy men for 12 days and can inform chronic protocols for reproductive disorders.
Limitations
Small groups.
PubMed 42549827DOI
✓ Positivehuman RCTJ Clin Endocrinol Metab · 2016

Interactions Between Neurokinin B and Kisspeptin in Mediating Estrogen Feedback in Healthy Women.

n = 10 humansTwo-way crossover of kisspeptin-10 vs vehicle infusion during estradiol, with NK3R antagonist (AZD4901) pretreatment7-hour infusion

Healthy women, randomized crossover: a 7-hour kisspeptin-10 infusion increased LH secretion during the estrogen-inhibitory phase; the study mainly examined interaction with neurokinin B signaling.

Key resultNK3R antagonist decreased LH pulse frequency (0.5 ± 0.2 vs 0.7 ± 0.2 pulses/h, P < .05); LH at 48 hours was lower (7.5 ± 4.8 vs 15.0 ± 11.4 IU/L, P < .05)
Studied
Healthy women with regular menses
Compared with
Vehicle infusion; no-treatment controls
Main outcome
Plasma gonadotropin secretion
Sample
10 women on NK3R antagonist, with 10 no-treatment controls
Authors' conclusion
NKB signaling regulates GnRH/LH secretion in normal women, predominantly proximal to kisspeptin in mediating estrogenic positive and negative feedback.
Limitations
Small sample.
PubMed 27636018DOIFree full text
Figure 3.: LH (A) and FSH (B) levels an hour before and during 7 hours of vehicle or kisspeptin-10 (Kp-10) infusion in the control group (n = 9) and in
Figure 3.. From PMC5155690, CC BY (terms); resized.
✓ Positivehuman trialClin Endocrinol (Oxf) · 2013

Exploring the pathophysiology of hypogonadism in men with type 2 diabetes: kisspeptin-10 stimulates serum testosterone and LH secretion in men with type 2 diabetes and mild biochemical hypogonadism.

n = 12 humansProof-of-concept physiology study, bolus and 11 h infusion

Proof-of-concept in 5 men with type 2 diabetes and low testosterone: IV kisspeptin-10 raised LH, LH pulse frequency and testosterone (8.5 to 11.4 nmol/L during infusion); healthy men responded similarly.

Key resultInfusion raised LH from 3.9 to 20.7 IU/l (P = 0.03) and testosterone from 8.5 to 11.4 nmol/l (P = 0.002).
Studied
Hypotestosteronaemic men with type 2 diabetes; healthy men
Main outcome
LH and testosterone
Sample
5 men with type 2 diabetes and low testosterone plus 7 age-matched healthy men
Authors' conclusion
Kisspeptin-10 increased LH pulse frequency and secretion and testosterone in men with T2DM; suggests a possible role for kisspeptin agonists in central hypogonadism.
Limitations
Five patients, uncontrolled infusion experiment.
PubMed 23153270DOI
~ Mixedhuman trialHormones (Athens) · 2026

Dynamic modulation of LH secretion by continuous kisspeptin infusion in healthy men.

n = 3 humansUncontrolled physiological study of continuous intravenous kisspeptin-1024 hours

Three healthy men on a 24-hour continuous kisspeptin-10 infusion: LH rose 5-8 fold then declined 13-47% from peak by end of infusion, suggesting partial attenuation; FSH and testosterone rose modestly.

Key resultLH rose from 2.8-3.8 to 17.5-30.6 mIU/mL, then fell 13-47% from maximum to end of infusion.
Studied
Healthy adult men
Main outcome
LH, FSH, testosterone
Sample
3 healthy men
Authors' conclusion
Continuous kisspeptin infusion is a complementary physiologic tool for studying GnRH-induced LH secretion; further studies are needed on receptor response to non-pulsatile ligand.
Limitations
Only 3 participants, no control.
PubMed 42230485DOIFree full text
~ Mixedhuman trialHum Reprod · 2012

Kisspeptin-10 stimulation of gonadotrophin secretion in women is modulated by sex steroid feedback.

Follicular-phase women, 6 post-menopausal women, and 8 women on contraceptives (combined pill 4, progestogen implants 4)Experimental study of IV kisspeptin-10 (0.3 µg/kg) bolus60 minutes of sampling

IV kisspeptin-10 (0.3 µg/kg) raised LH in follicular-phase women, postmenopausal women and progestogen users, but not in women on the combined pill; FSH rose only in postmenopausal women.

Key resultLH ΔAUC: follicular 2.3 ± 0.8 IU/l h (P = 0.009), post-menopausal 5.3 ± 0.9 (P 0.002), combined pill 0.9 ± 0.4 (P 0.13, not significant)
Studied
Women in early follicular phase, post-menopausal women, and women on sex-steroid contraceptives
Compared with
Between sex-steroid milieus
Main outcome
LH and FSH area under the curve
Authors' conclusion
Kisspeptin-10 stimulates gonadotrophin secretion in women, and the pituitary gonadotrope appears to be an important locus of estrogen feedback.
Limitations
Only acute responses to a single IV bolus assessed.
PubMed 22956346DOI
~ Mixedhuman trialAndrologia · 2019

Age-dependent changes in the reproductive axis responsiveness to kisspeptin-10 administration in healthy men.

HumansSingle IV bolus of kisspeptin-10 (1 µg/kg) with serial sampling30 min before to 120 min after injection

Single IV bolus (1 µg/kg) in healthy young, middle-aged and older men: LH rose in all groups, but testosterone rose significantly only in the younger adult group.

Key resultLH rose significantly (p < 0.05) in all groups; testosterone rose significantly (p < 0.05) only in the adult group
Studied
Healthy adult, middle-aged and older men
Compared with
Pre-injection baseline across age groups
Main outcome
Plasma LH and testosterone
Authors' conclusion
The central hypothalamic-pituitary axis stays responsive to kisspeptin across life, but Leydig cell responsiveness to kisspeptin-induced LH decreases with age.
Limitations
Sample size not stated in the abstract.
PubMed 30590872DOI
✓ Positivehuman trialJ Clin Endocrinol Metab · 2011

Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men.

HumansDose-response of IV bolus kisspeptin-10 vs vehicle, then infusion for up to 22.5 hUp to 22.5 h infusion

First kisspeptin-10 study in men: IV boluses of kisspeptin-10 raised LH dose-dependently (peak 1 microgram/kg, LH 4.1 to 12.4 IU/L), and infusion raised testosterone, LH pulse frequency and pulse size.

Key resultAt 30 min, LH rose from 4.1 +/- 0.4 to 12.4 +/- 1.7 IU/liter (P < 0.001, n = 6) at 1 microgram/kg; 22.5-h infusion raised testosterone from 16.6 to 24.0 nmol/liter (P < 0.001).
Studied
Healthy men
Compared with
Vehicle
Main outcome
LH concentration, pulse frequency and testosterone
Authors' conclusion
Kisspeptin-10 boluses potently evoke LH secretion in men and continuous infusion increases testosterone, LH pulse frequency and size; analogues have therapeutic potential.
Limitations
Very small groups (n = 4-6 per experiment).
PubMed 21632807DOIFree full text
~ Mixedhuman trialHum Reprod · 2015

Direct comparison of the effects of intravenous kisspeptin-10, kisspeptin-54 and GnRH on gonadotrophin secretion in healthy men.

HumansSingle-blinded placebo-controlled physiological study of kisspeptin-10, kisspeptin-54 and GnRH3 h infusions on separate study days

Five men per dose group: IV kisspeptin-10 and kisspeptin-54 raised LH and FSH similarly but GnRH was about 3-fold more potent than kisspeptin-10; small single-blinded study.

Key resultMean LH AUC 10.81 +/- 1.73 h.IU/l (kisspeptin-10), 14.43 +/- 1.27 (kisspeptin-54), 34.06 +/- 5.18 (GnRH) at 1.0 nmol/kg/h.
Studied
Healthy men, 5 per dosing group
Compared with
Vehicle and GnRH
Main outcome
Serum LH and FSH
Authors' conclusion
The two kisspeptin isoforms gave similar gonadotrophin secretion at the doses tested; GnRH was more potent than either.
Limitations
Small sample size, as the authors note.
PubMed 26089302DOIFree full text
Figure 3: Change in serum LH levels during intravenous administration of kisspeptin-10, kisspeptin-54 and GnRH to healthy men. Time profiles of mean c
Figure 3. From PMC4507333, CC BY (terms); resized.

Animal & lab studies

✓ PositiveanimalHorm Metab Res · 2014

Primate HPT axis response to the peripheral kisspeptin challenge under different time periods of food restriction in monkeys.

n = 5 animalsIV boluses of vehicle and human kisspeptin-10 (50 μg) in each condition3-hour post-injection period

In adult male rhesus monkeys, IV kisspeptin-10 stimulated testosterone in fed and fasted states, but the response was smaller and slower after 18-24 hours of fasting.

Key resultMean testosterone in the 3-h post-KP10 period was significantly lower in 18- and 24-h fasted monkeys than in 12-h fasted and fed monkeys (p<0.01)
Studied
Adult male rhesus monkeys fasted 12, 18 or 24 h, or fed ad libitum
Compared with
Fed and vehicle conditions
Main outcome
Testosterone response
Sample
5 sexually mature male rhesus monkeys
Authors' conclusion
18- and 24-h fasting suppressed the testosterone response to kisspeptin in onset and amount, which may partly involve attenuated responsiveness to endogenous kisspeptin.
Limitations
Five monkeys.
PubMed 24500987DOI
✓ PositiveanimalProc Natl Acad Sci U S A · 2005

Increased hypothalamic GPR54 signaling: a potential mechanism for initiation of puberty in primates.

AnimalsKisspeptin-10 injection with LH measurement; hypothalamic KiSS-1 and GPR54 mRNA expression

In juvenile male monkeys, IV or intracerebroventricular kisspeptin-10 triggered robust GnRH-driven LH release, abolished by a GnRH-receptor antagonist.

Key resultHypothalamic GPR54 mRNA increased approximately 3-fold from juvenile to midpubertal stage in intact females
Studied
Agonadal juvenile male monkeys and peripubertal monkeys
Compared with
GnRH-receptor antagonist pretreatment
Main outcome
LH secretion (GnRH release); KiSS-1 and GPR54 mRNA
Authors' conclusion
GPR54 signaling in the primate hypothalamus may be activated at the end of the juvenile phase and contribute to pubertal resurgence of pulsatile GnRH release.
Limitations
Monkey study.
PubMed 15684075DOIFree full text

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.