Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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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