RCTNCT01667406Phase 2 · 2012 · n=175 · Imperial College London Infertility
tested Percentage of Oocyte Maturation
RCTNCT04532801Phase 1 · 2019 · Stephanie B. Seminara, MD Pharmacokinetic / healthy volunteer studies
tested Beta-cell responsivity index
result Withdrawn before enrolment
Withdrawn: Interim analysis of data collected under other clinical trials demonstrated planned enrollment was insufficiently powered.
RCTNCT04958109Phase 1 · 2021 · n=16 · Massachusetts General Hospital Metabolic Diseases
tested Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
result −4.0 ml min-1m-2 (Oral Glucose Sensitivity Index (Kisspeptin-Placebo…)
Small sample; effect at the edge of clinical significance.
RCTNCT05456854Phase 1 · 2022 · Massachusetts General Hospital Metabolic Disease
tested First Phase Insulin Secretion
result Withdrawn before enrolment
Withdrawn: Futility
Treatment studies
tested safety, tolerability, pharmacokinetics, and pharmacodynamics (testosterone, LH, FSH suppression)
result TAK-683 2.0 mg/day suppressed testosterone below castration level (<50 ng/dL) in 4/5 subjects by day 7; LH suppressed up to 70%, FSH up to 43% vs placebo.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested LH surge amplitude/duration, time to ovulation (TVU), safety/tolerability, pharmacokinetics
result 3 μg MVT-602: mean max LH change 82.4 IU/L at 24.8 h, sustained >15 IU/L for 33 h; ovulation within 5 days in 100% (3 μg) vs 60% placebo; time to ovulation 3.3–3.9 days vs 5.5 days placebo.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Dynamic serum and follicular-fluid kisspeptin levels at 4 COH timepoints; correlation with oocyte yield, embryo quality, clinical pregnancy rate, and live birth rate
result PCOS had higher serum/FF kisspeptin at all timepoints; clinical pregnancy rate 8.54% vs 35.06% (p=0.014); live birth rate lower in PCOS; dOPU kisspeptin AUC=0.655 for pregnancy prediction.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested LH and FSH levels via frequent blood sampling over 24h
result Continuous kisspeptin-10 infusion caused immediate 5–10× baseline LH rise sustained for hours, then declined but remained above baseline; modest FSH rise also observed.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
OpenNCT00914823Phase 1 · 2009 · n=256 · Massachusetts General Hospital Hypogonadotropic Hypogonadism
tested Average change in luteinizing hormone (LH) in response to kisspeptin
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT01438034Phase 1 · 2013 · n=24 · Massachusetts General Hospital Delayed Puberty
tested Average change in luteinizing hormone (LH) in response to kisspeptin
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT01438073Phase 1 · 2011 · n=96 · Massachusetts General Hospital Hypogonadotropic Hypogonadism
tested Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT01952782Phase 1 · 2014 · n=61 · Massachusetts General Hospital Hypogonadotropic Hypogonadism
tested Average difference in luteinizing hormone (LH) concentration before and after kisspeptin
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT02956447Phase 2 · 2017 · n=36 · Massachusetts General Hospital Hyperprolactinemia
tested Average Change in Number of Luteinizing Hormone (LH) Pulses Over 10 Hours
Non-randomised; effect size cannot be separated from placebo.
OpenNCT04648969Phase 2 · 2019 · n=18 · Stephanie B. Seminara, MD Hypogonadotropic Hypogonadism
tested Average change in luteinizing hormone (LH) pulse amplitude in response to kisspeptin
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05633966Phase 1 · 2022 · n=13 · Stephanie B. Seminara, MD Hypothalamic Amenorrhea
tested The proportion of participants that achieve development of a mature follicle or show evidence of ovulation
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05896293Phase 2 · 2023 · n=36 · Stephanie B. Seminara, MD Hypogonadotropic Hypogonadism
tested Average change in luteinizing hormone (LH) pulse amplitude
result In progress (recruiting)
Non-randomised; effect size cannot be separated from placebo.
OpenNCT05901467Phase 1 · 2023 · n=16 · Stephanie B. Seminara, MD Reproductive Disorder
tested Endogenous LH Pulse Amplitude
result Terminated before completion
Terminated: The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.
OpenNCT05971849Phase 1 · 2023 · n=8 · Stephanie B. Seminara, MD Reproductive Disorder
tested Average change in LH pulse frequency
result Completed; results not posted
Non-randomised; effect size cannot be separated from placebo.
OpenNCT07224438Phase 2 · 2025 · n=20 · Stephanie B. Seminara, MD Hypothalamic Amenorrhea
tested Change of luteinizing hormone (LH) pulse amplitude
result In progress (recruiting)
Non-randomised; effect size cannot be separated from placebo.
OpenNCT07224490Phase 1 · 2026 · n=40 · Stephanie B. Seminara, MD Reproductive Disorder
tested Difference in mean luteinizing hormone (LH) amplitude between cases and controls
result In progress (recruiting)
Non-randomised; effect size cannot be separated from placebo.
Diagnostic & mechanistic studies
tested plasma LH, FSH, and testosterone concentrations
result Kisspeptin-54 significantly increased LH (10.8 vs 4.2 U/L), FSH (3.9 vs 3.2 U/L), testosterone (24.9 vs 21.7 nmol/L) vs saline (all P<0.001); plasma t½ 27.6 min.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested plasma metastin-like immunoreactive substance (LI) levels vs clinicopathological factors
result Plasma metastin-LI significantly higher in cancer patients vs healthy volunteers; no significant relationship with tumor size, invasion, lymph node or distant metastasis.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested plasma metastin (kisspeptin) levels and correlations with LH, testosterone, 2-h glucose
result Plasma metastin elevated in adolescent PCOS vs controls; positively correlated with LH, T, and 2-h glucose levels; may affect PCOS development in adolescents.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested serum LH, LH pulse frequency, LH pulse secretory burst mass, serum testosterone
result Bolus 1 μg/kg: LH 4.1→12.4 IU/L (P<0.001). Infusion 4 μg/kg·h: LH 5.4→20.8 IU/L, testosterone 16.6→24.0 nmol/L. Infusion 1.5 μg/kg·h: LH pulse freq 0.7→1.0/h, burst mass 3.9→12.8 IU/L.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested First-trimester serum metastin (kisspeptin) levels as biomarker for pre-eclampsia prediction
result Metastin lower in pre-eclampsia (1554±385 vs 1995±375 pmol/L, p<0.001); AUC=0.797 for pre-eclampsia prediction; PIGF AUC=0.831.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested LH secretion, LH pulse frequency, serum testosterone
result 0.3 mcg/kg bolus raised LH from 4.7 to 10.7 IU/l in T2DM men (P=0.02); 11h infusion raised LH to 20.7 IU/l and testosterone from 8.5 to 11.4 nmol/l (P=0.002).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Plasma LH and FSH secretion; LH pulse frequency
result Kisspeptin-10 increased LH during inhibitory phase; NK3R antagonist reduced LH pulse frequency (0.5 vs 0.7 pulses/h), blunted LH at 48h (7.5 vs 15.0 IU/L), amplified FSH response to kisspeptin (10.7 vs 5.0 IU/L).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested plasma LH and testosterone levels pre- and 120 min post-kisspeptin-10 IV bolus
result No significant LH/testosterone response at Tanner stages I–III; at stage V, LH and testosterone significantly increased (P<0.05) vs pre-kisspeptin; KISS1R sensitivity reaches adult level at Tanner stage V.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested plasma LH and testosterone concentrations over 120 min post-injection
result LH increased significantly (p<0.05) in all age groups. Testosterone elevated (p<0.05) only in adult men. Leydig cell LH responsiveness declines with age.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested plasma irisin levels measured every 30 min for 240 min
result Irisin rose significantly in normal-weight (59.18→96.24 ng/mL at 210 min, P<0.0001) and obese men (41.28→75.76 ng/mL at 180 min, P<0.0001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested LH secretion, LH pulse frequency, FSH secretion
result Kisspeptin-10 raised LH (5.2±0.5→7.8±1.0 IU/L, P<0.05); NK3Ra reduced LH (4.0±0.4 vs 6.5±0.8 IU/l) and pulse frequency; kisspeptin LH response preserved post-NK3Ra.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Serum kisspeptin levels at days 14, 21, 28 post-FET as predictors of first-trimester miscarriage
result Day 14 kisspeptin not discriminatory (p=0.551). Days 21 and 28 significantly lower in miscarriage group but poor AUC vs HCG (D21: 0.687 vs 0.816; D28: 0.896 vs 0.909).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Kisspeptin AUC and peak levels following IV GnRH vs placebo injection
result Baseline kisspeptin 9.9–201.6 pg/mL; no significant reduction in kisspeptin AUC or peak after GnRH vs placebo; no negative feedback of GnRH on kisspeptin detected.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested state anxiety (psychometric), cortisol, LH, heart rate, blood pressure
result LH robustly increased (P<.001); state anxiety not significantly altered (P=.13); cortisol (P=.73), systolic BP (P=.74), diastolic BP (P=.90), heart rate (P=.52) all unchanged.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Treatment studies
tested serum luteinising hormone (LH) peak rise from baseline
result Intranasal kisspeptin-54 (12.8 nmol/kg) increased LH vs placebo: healthy men +3.1 IU/L (P=0.002), healthy women +1.0 IU/L (P=0.004), hypothalamic amenorrhoea +4.3 IU/L (P<0.001).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested serum and seminal plasma kisspeptin as biomarkers distinguishing fertile from infertile men
result Serum kisspeptin higher in infertile groups (B: 109.37, C: 108.70 ng/dL) vs fertile (85.18 ng/dL; p=0.019); seminal plasma not significantly different (p=0.48).
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested LH, FSH, and testosterone concentrations over 24 h
result LH rose 5–8× above baseline (2.8–3.8 → 17.5–30.6 mIU/mL) within 12–20 h, then declined 13–47% by infusion end; FSH and testosterone rose modestly.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Diagnostic & mechanistic studies
tested Serum and follicular fluid kisspeptin levels at 4 timepoints; correlation with COH outcomes, TQE rate, cumulative pregnancy rate, live birth rate; ROC AUC for pregnancy prediction
result PCOS had higher kisspeptin at all timepoints; cumulative pregnancy rate 40% vs 60% (P=0.046); live birth rate 8.54% vs 35.06% (P=0.014); dOPU serum kisspeptin AUC=0.655 for pregnancy.
Published human study (PubMed / Europe PMC), extracted from its abstract — not a CT.gov-registered trial.
Preclinical / mechanistic research
tested animal model · Bioengineered recombinant kisspeptins with extended half-life exhibit novel peripheral function in a large-animal model
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Functional interactions between anteroventral periventricular kisspeptin neurons and gonadotropin-releasing hormone neurons in female mice
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · 2-acylamino-4,6-diphenylpyridine derivatives as novel GPR54 antagonists with good brain exposure and in vivo efficacy for plasma LH level in male rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Kissorphin improves spatial memory and cognitive flexibility impairment induced by ethanol treatment in the Barnes maze task in rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Intraperitoneal kisspeptin-10 administration ameliorates sodium arsenite-induced reproductive toxicity in adult male mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Gonadal Feedback Alters the Relationship between Action Potentials and Hormone Release in Gonadotropin-Releasing Hormone Neurons in Male Mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Intraperitoneal administration of mouse kisspeptin-10 to mice during estrus stage induces pseudopregnancy.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Investigation of the Effects of Boric Acid against Post Operative Testicular Adhesion Caused by Experimental Laporotomy in Rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · Central administration of p234, kisspeptin antagonist, but not kisspeptin-10, reduces the power of epileptiform activity and slow EEG waves in male rats.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rabbit · Effects of Kisspeptin on rabbit ovulation: a comprehensive study of ovulatory, endocrine and histological response.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested mouse · Altered Electrophysiology and Transcriptome of GnRH Neurons in Middle-Aged Female Mice.
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested rat · [Effect of acupuncture on ovarian function in rats with premature ovarian insufficiency based on kisspeptin/GPR54 pathway].
result Preclinical publication captured from PubMed/Europe PMC; effect details require paper-level extraction.
Preclinical / mechanistic research
tested The role of tryptophans on the cellular uptake and membrane interaction of arginine-rich cell penetrating peptides.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Kisspeptin as a promising oocyte maturation trigger for in vitro fertilisation in humans.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Kisspeptin-10 Rescues Cholinergic Differentiated SHSY-5Y Cells from α-Synuclein-Induced Toxicity In Vitro.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Kisspeptin (Kp-10) inhibits in vitro osteogenic differentiation of multipotent mesenchymal stromal cells extracted from the bone marrow of adult rats.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Comprehensive Analysis of Kisspeptin Signaling: Effects on Cellular Dynamics in Cervical Cancer.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Influence of neurokinin B, dynorphin A and kisspeptin-10 on <i>in vitro</i> gonadotropin secretion by anterior pituitary cells isolated from pubescent ewes.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested Effect of neurokinin B and dynorphin A on kisspeptin-10 secretion from the anterior pituitary cells of pubescent ewes <i>in vitro</i>.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.
Preclinical / mechanistic research
tested High-Fat Diet Promotes Glycolysis in Hepatocellular Carcinoma by Suppressing Hepatic Kisspeptin Signaling in Mice.
result In-vitro publication captured from PubMed/Europe PMC; assay details require paper-level extraction.