Dampening the Reproductive Axis With Continuous Kisspeptin

November 3, 2025 updated by: Stephanie B. Seminara, MD
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kisspeptin
IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.
Drug: kisspeptin 112-121
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
Other Names:
  • metastin 45-54

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average change in LH pulse frequency
Time Frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
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
Time Frame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stephanie B. Seminara, MD

Investigators

  • Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Actual)

April 27, 2024

Study Completion (Actual)

April 27, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Estimated)

November 5, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P001356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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