Dampening the Reproductive Axis With Continuous Kisspeptin

NCT ID: NCT05971849

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-06
• Study Completion Date: 2024-04-27

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).

Detailed Description

Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.

Delivery of Interventions:

• Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
• On the day of the study, the subjects will have an intravenous (IV) line placed and

• Undergo up to q10 min blood sampling x 36 hours
• Receive an infusion of kisspeptin x 24 hours
• Receive up to two kisspeptin IV boluses

Conditions

Reproductive Disorder; PCOS; Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

kisspeptin

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

Group Type: EXPERIMENTAL

kisspeptin 112-121

Intervention Type: DRUG

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

Interventions

kisspeptin 112-121

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

Intervention Type: DRUG

Other Intervention Names

metastin 45-54

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stephanie B. Seminara, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephanie B Seminara, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2023P001356

Identifier Type: -

Identifier Source: org_study_id