Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05896293

Kisspeptin Administration Subcutaneously to Patients With IHH

Led by Stephanie B. Seminara, MD · Updated on 2025-10-03

36

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD

CONDITIONS

Official Title

Kisspeptin Administration Subcutaneously to Patients With IHH

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of congenital idiopathic hypogonadotropic hypogonadism (IHH) by a medical provider, supported by low sex steroids and low or inappropriately normal gonadotropins
  • Normal blood pressure (systolic below 140 mm Hg, diastolic below 90 mm Hg)
  • No current or recent use of medications that can affect the reproductive axis, or willingness to complete a washout period for such medications
Not Eligible

You will not qualify if you...

  • Any medical, mental, or behavioral condition that could interfere with study participation or completion
  • Excessive alcohol consumption (more than 10 drinks per week) or active use of illicit drugs
  • Active marijuana use will be evaluated for impact on participation
  • Pregnant, trying to become pregnant, or breastfeeding
  • History of bilateral oophorectomy, breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

S

Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Kisspeptin Administration Subcutaneously to Patients With IHH | DecenTrialz