Clinical trial · Interventional
Kisspeptin Administration in the Adult
Administration of Kisspeptin to Subjects With Reproductive Disorders
NCT00914823CI-TRIAL-00079299completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GnRH Deficiency | — | UNRESOLVED | — |
| Hyperprolactinemia | — | UNRESOLVED | — |
| Hypogonadotropic Hypogonadism | — | UNRESOLVED | — |
| Kallmann Syndrome | — | UNRESOLVED | — |
| PCOS | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH | Drug | — | UNRESOLVED |
| kisspeptin 112-121 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- kisspeptin, GnRH
- description
- Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH
- interventionNames
- Drug: kisspeptin 112-121
- Drug: GnRH
Primary outcomes (1)
- measure
- Average change in luteinizing hormone (LH) in response to kisspeptin
- timeFrame
- Within 30 minutes of administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
A. Healthy Subjects All healthy subjects will meet the following criteria: * normal puberty with respect to onset and pace, * no chronic diseases, * no difficulty with blood draws, * no prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy, * no illicit drug use or excessive alcohol consumption (\< 10 drinks/week), * no history of a medication reaction requiring emergency medical care, * normal physical exam and laboratory studies within protocol reference ranges. Additional criteria based on subject population: 1. Healthy Men: * between 21 and 40 years old, * normal erectile and ejaculatory function, no history of reproductive disorders, * testicular volume \>15 ml. 2. Healthy women: * between 21 and 40 years old, * not breastfeeding or pregnant, * menstrual cycles between 25 and 35 days in duration, at least 11 periods/year, with no more than 5 days variability in cycle duration, * no evidence for androgen excess (hirsutism or acne), * at screening, negative hCG pregnancy test, * negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study. 3. Healthy postmenopausal women: * between 50 and 60 years old, * no menstrual periods within the last year, * previous history of menstrual cycles between 25 and 35 days in duration, with no more than 5 days variability in cycle duration, * if applicable, able to undergo washout from hormone therapy, * no evidence for androgen excess (hirsutism or acne), * negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study. B. Subjects with Reproductive Disorders All subjects with reproductive disorders will meet the following criteria: * 18 years or older, * all medical conditions stable and well controlled, * no prescription medications known to affect reproductive endocrine function for at least 2 months except for medications used to treat the subject's reproductive condition, * no history of a medication reaction requiring emergency medical care, * no illicit drug use or excessive alcohol consumption (\<10 drinks/week), * for women, not breastfeeding or pregnant, * if applicable, able to undergo appropriate washout from hormone therapy, * normal physical exam and laboratory studies within protocol reference ranges, * for women, at time of screening negative hCG pregnancy test. Additional criteria based on subject population: 1. Men and women with hypogonadotropic hypogonadism, * Confirmed diagnosis by low sex steroids in the setting of low or inappropriately normal gonadotropins, * If needed, additional labs and imaging tests may be performed. 2. Women with Polycystic Ovarian Syndrome (PCOS) * Confirmed diagnosis of PCOS, * If needed, additional labs and imaging tests may be performed. 3. Men and women with hyperprolactinemia * confirmed diagnosis of elevated levels of prolactin measured via blood test, * no pituitary adenoma OR a microprolactinoma (\<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded, * willing to complete a dopamine agonist washout.
References
Publications (4)
- DERIVEDGalbiati F, Plessow F, Plummer L, Campbell MB, Nazarloo S, Carter CS, Davis JM, Miller KK, Carroll RS, Kaiser UB, Seminara SB, Aulinas A, Lawson EA. Intravenous kisspeptin 112-121 bolus does not acutely impact circulating vasopressin in humans. J Neuroendocrinol. 2026 Jan;38(1):e70114. doi: 10.1111/jne.70114. Epub 2025 Nov 22. PMID 41273106
- DERIVEDGalbiati F, Plessow F, Plummer L, Campbell MB, Nazarloo S, Carter CS, Carroll RS, Kim HK, Pereira SA, Paulis D, Davis JM, Miller KK, Kaiser UB, Seminara SB, Aulinas A, Lawson EA. Sex-dependent increases in oxytocin levels in response to intravenous kisspeptin in humans. Eur J Endocrinol. 2025 Mar 3;192(3):K24-K29. doi: 10.1093/ejendo/lvaf001. PMID 39965102
- DERIVEDLippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146. PMID 31132118
- DERIVEDChan YM, Lippincott MF, Butler JP, Sidhoum VF, Li CX, Plummer L, Seminara SB. Exogenous kisspeptin administration as a probe of GnRH neuronal function in patients with idiopathic hypogonadotropic hypogonadism. J Clin Endocrinol Metab. 2014 Dec;99(12):E2762-71. doi: 10.1210/jc.2014-2233. PMID 25226293