Actively Recruiting
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Led by Stephanie B. Seminara, MD · Updated on 2025-12-31
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stephanie B. Seminara, MD
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether kisspeptin, a natural hormone, can stimulate the release of reproductive hormones and help women with hypothalamic amenorrhea (HA) release eggs from their ovaries. The study focuses on women with acquired hypothalamic amenorrhea or functional hypogonadotropic hypogonadism. This Phase 2 trial aims to understand kisspeptin's effects on hormone release and ovarian function. Participants will receive kisspeptin through a pump that delivers the hormone subcutaneously in a pulsatile manner approximately every 90 minutes over two weeks. During this period, they will undergo frequent blood sampling every 10 minutes for about two hours on four separate occasions, along with pelvic ultrasounds to monitor ovarian follicle growth. Optional longer blood sampling sessions of up to 10 hours may also occur before and after treatment. Throughout the study, participants will have their medical history reviewed and physical exams conducted, including screening lab tests and baseline pelvic ultrasounds. Researchers will closely monitor hormone levels and follicular growth to assess kisspeptin's physiological effects. The primary measure is the change in luteinizing hormone (LH) pulse amplitude after two weeks of treatment. Safety and adherence will be observed throughout the study, which is expected to last several weeks from screening to treatment completion.
CONDITIONS
Brief Title
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Ages 18-45 years
- Diagnosed with acquired hypothalamic amenorrhea or functional hypogonadotropic hypogonadism
- Normal blood pressure (systolic less than 140 mm Hg and diastolic less than 90 mm Hg)
- Hemoglobin not more than 0.5 g/dL below the lower normal limit for women
- Negative pregnancy test (serum hCG)
- No current or recent use of medications affecting reproductive hormones or willing to complete a medication washout
- Willing to use approved birth control during the study and for one month after last study drug dose, if applicable
You will not qualify if you...
- Any medical, mental, or behavioral condition that may interfere with study participation or completion
- Excessive alcohol use (more than 10 drinks per week)
- Active use of illicit drugs
- Pregnant or trying to become pregnant during the study
- Breastfeeding
- History of bilateral ovary removal, breast cancer, blood clots, heart disease, stroke, clotting 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.
Duration - 2 weeks
Participants receive subcutaneous administration of kisspeptin using a pump for two weeks with pulsatile dosing approximately every 90 minutes.
1 pump placement visit and multiple blood sampling and ultrasound sessions 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
TREATMENT
Number of Arms
1
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