Last reviewed · How we verify
NCT01952782
Neuropeptides in Human Reproduction
Phase 1 trial testing Kisspeptin 112-121 in Hypogonadotropic Hypogonadism in 61 participants. Completed in 31 May 2016.
31 May 2016
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 61 |
| Start date | 30 April 2014 |
| Primary completion | 31 May 2016 |
| Estimated completion | 31 May 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Kisspeptin 112-121 — full drug profile →
- Naloxone (NALOXONE) — full drug profile →
- GnRH — full drug profile →
Conditions studied
- Hypogonadotropic Hypogonadism — all drugs for Hypogonadotropic Hypogonadism →
Sponsor
Massachusetts General Hospital
Who can join
Adults 18 to 75, any sex, with Hypogonadotropic Hypogonadism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators are seeking healthy volunteers and volunteers with reproductive disorders for the study of the role of dynorphin in the reproductive system. Dynorphin is a naturally occurring opioid hormone that is blocked by naloxone. We hypothesize that naloxone, by blocking dynorphin, will stimulate production of gonadotropin-releasing hormone (GnRH) and kisspeptin, two other naturally occurring reproductive hormones.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling.
Lippincott MF, León S, Chan YM, Fergani C, et al · · 2019 · cited 25× · PMID 31132118 · DOI 10.1210/jc.2019-00146 -
Divergent responses to kisspeptin in children with delayed puberty.
Chan YM, Lippincott MF, Kusa TO, Seminara SB. · · 2018 · cited 15× · PMID 29669934 · DOI 10.1172/jci.insight.99109 -
Kisspeptin a potential therapeutic target in treatment of both metabolic and reproductive dysfunction.
Sliwowska JH, Woods NE, Alzahrani AR, Paspali E, et al · · 2024 · cited 9× · PMID 38599822 · DOI 10.1111/1753-0407.13541 -
Kisspeptin Receptor Agonists and Antagonists: Strategies for Discovery and Implications for Human Health and Disease.
Chen X, Yang S, Shaw ND, Xia M. · · 2025 · cited 1× · PMID 40430029 · DOI 10.3390/ijms26104890
Verify or expand the search:
- PubMed search for NCT01952782
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Kisspeptin 112-121
Trials testing the same drug.
- NCT05633966 — Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders · Phase 1 · completed
- NCT02956447 — Administration of Kisspeptin in Patients With Hyperprolactinemia · Phase 2 · completed
Other recruiting trials for Hypogonadotropic Hypogonadism
Currently open trials in the same condition.
- NCT06357442 — Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Dail · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01952782 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 31 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01952782.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing