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OpenTrials
Completed

NCT Number: NCT05971849

Dampening the Reproductive Axis With Continuous Kisspeptin

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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Kisspeptin 112-121

Drug

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

Other names: metastin 45-54

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Stephanie B. Seminara, MD

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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