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
229 weeks
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
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
CONDITIONS
Official Title
Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Ages 18-45 years
- Acquired hypothalamic hypogonadism (hypothalamic amenorrhea)
- Normal blood pressure (systolic < 140 mm Hg, diastolic < 90 mm Hg)
- Hemoglobin within 0.5 g/dL of the lower limit of normal for women
- Negative serum hCG pregnancy test
- No current or recent use of medications affecting the reproductive axis, or willing to complete a washout period
- Willing to use approved birth control during the study and for one month after last 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 breastfeeding
- Trying to become pregnant during the study
- History of bilateral oophorectomy, breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or unexplained abnormal genital bleeding
AI-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
TREATMENT
Number of Arms
1
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