Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

NCT ID: NCT07224438

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-09
• Study Completion Date: 2030-05-31

Brief 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.

Detailed Description

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

• The subject will undergo a review of their medical history, physical exam, and screening laboratories.
• A pelvic ultrasound will be performed to assess baseline follicular size.
• A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
• During the course of kisspeptin administration, subjects will
• Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
• Undergo pelvic ultrasounds (approximately 4 sessions)
• Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin

Conditions

Hypothalamic Amenorrhea; Hypogonadotropic Hypogonadism

Keywords

hypothalamic amenorrhea; hypogonadotropic hypogonadism; kisspeptin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kisspeptin pump

SC administration of kisspeptin for two weeks (pulsatile)

Group Type: EXPERIMENTAL

kisspeptin 112-121

Intervention Type: DRUG

SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)

Interventions

kisspeptin 112-121

SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)

Intervention Type: DRUG

Other Intervention Names

Metastin 45-54

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
• Excessive alcohol consumption (>10 drinks/week)
• Active use of illicit drugs
• Pregnant
• Trying to become pregnant during protocol participation
• Breast feeding
• History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Stephanie B. Seminara, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

Phone: 617-643-2308

Email: MGHKisspeptinResearch@partners.org

Facility Contacts

Study Coordinator

Role: primary

Other Identifiers

R37HD043341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

565178

Identifier Type: -

Identifier Source: org_study_id