Dampening the Reproductive Axis With Continuous Kisspeptin

NCT05971849 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2023P001356
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).

Conditions

Reproductive Disorder; PCOS; Polycystic Ovary Syndrome

Keywords

reproductive disorders; kisspeptin; PCOS

Outcome Measures

Primary Outcomes (2)

• Average change in LH pulse frequency

  Average change in LH pulse frequency before and during kisspeptin infusion

  6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

• Average change in LH pulse amplitude

  Average change in LH pulse amplitude before and during kisspeptin infusion

  6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion

Study Arms (1)

kisspeptin

EXPERIMENTAL

IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.

Drug: kisspeptin 112-121

Interventions

kisspeptin 112-121 DRUG

IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin

Also known as: metastin 45-54

kisspeptin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

* Ages 18-45 years * A history of clinical diagnosis of PCOS or equivalent clinical features * BMI \>18.5 and \<35 kg/m2 * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \> 90 mm Hg) * Laboratory studies: * Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women * Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of administration * No current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration * No excessive alcohol consumption (\>10 drinks/week) and/or ongoing use of illicit drugs • Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation * Not pregnant or trying to become pregnant * Not breastfeeding * No history of bilateral oophorectomy (both ovaries removed)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Stephanie B Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 2, 2023
• Study Start: October 6, 2023
• Primary Completion: April 27, 2024
• Study Completion: April 27, 2024
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)