Image

Dampening the Reproductive Axis With Continuous Kisspeptin

Dampening the Reproductive Axis With Continuous Kisspeptin

Not Recruiting
18-45 years
Female
Phase 1

Powered by AI

Overview

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).

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

Eligibility

  • 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 details
    Reproductive Disorder
    PCOS
    Polycystic Ovary Syndrome

NCT05971849

Stephanie B. Seminara, MD

5 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.