Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• Female

• Ages 18-45 years

• Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)

• Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)

• Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women

• Negative serum hCG pregnancy test

• No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis OR willing to complete an appropriate washout for that particular medication and its method of administration

• If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Study Coordinator
MGHKisspeptinResearch@partners.org
617-643-2308
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2030-05
Participants
Target number of participants: 20
Treatments
Experimental: Kisspeptin pump
SC administration of kisspeptin for two weeks (pulsatile)
Sponsors
Leads: Stephanie B. Seminara, MD
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov