Actively Recruiting
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Led by Stephanie B. Seminara, MD · Updated on 2025-10-03
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether kisspeptin, a natural hormone, can stimulate the release of reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). They are also exploring if kisspeptin can help women release eggs from their ovaries. This is a phase 2 clinical trial funded by the FDA Office of Orphan Products Development (OOPD). The trial aims to understand kisspeptin's effects on hormone release and ovarian function in this specific condition. Participants will receive kisspeptin administered subcutaneously through a pump that delivers the hormone in pulses every 60 to 240 minutes for two weeks. Before starting kisspeptin, some participants may receive a single injection of leuprolide acetate about six days earlier. Women will have pelvic ultrasounds to monitor follicle growth, and blood samples will be taken frequently during treatment to measure hormone responses. Optional extended blood sampling sessions may also occur before and after the two-week treatment. During the study, participants will undergo medical history reviews, physical exams, and screening lab tests. Women will have ultrasound scans to track follicular development, and all participants will have blood drawn every 10 minutes during certain sessions to assess luteinizing hormone activity. Researchers will measure changes in hormone pulse amplitude over two weeks and, for women, the presence of mature follicles or ovulation. The total participation timeline includes these assessments alongside kisspeptin administration and follow-up monitoring.
CONDITIONS
Brief 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) supported by low sex steroids with low or inappropriately normal gonadotropins
- Normal blood pressure (systolic below 140 mm Hg and diastolic below 90 mm Hg)
- No current or recent use of medications that affect the reproductive axis, or willingness to complete appropriate medication washout
- Adults aged 18 years or older
You will not qualify if you...
- Any medical, mental, or behavioral condition likely to interfere with completing the study
- Excessive alcohol use (more than 10 drinks per week) or active illicit drug use
- Pregnant, trying to become pregnant, or breastfeeding
- History of bilateral oophorectomy, breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or unexplained abnormal genital bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical history review, physical exam, and screening labs
Duration - Approximately 6 days
Participants may receive a single subcutaneous injection of leuprolide acetate approximately six days before starting kisspeptin treatment.
1 visit (in-person) for injection administration
Duration - 2 weeks
Participants receive pulsatile subcutaneous kisspeptin administered by a pump for two weeks.
Approximately 10 sessions of 70-minute blood sampling every 10 minutes and about 4 pelvic ultrasounds for women during treatment
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Study Coordinator
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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