Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

NCT07224438 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 565178R37HD043341
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothalamic Amenorrhea; Hypogonadotropic Hypogonadism

Keywords

hypothalamic amenorrhea; hypogonadotropic hypogonadism; kisspeptin

Outcome Measures

Primary Outcomes (1)

• Change of luteinizing hormone (LH) pulse amplitude

  Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration

  2 weeks

Other Outcomes (1)

• The proportion of participants that achieve development of a mature follicle or show evidence of ovulation

  2 weeks

Study Arms (1)

Kisspeptin pump

EXPERIMENTAL

SC administration of kisspeptin for two weeks (pulsatile)

Drug: kisspeptin 112-121

Interventions

kisspeptin 112-121 DRUG

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

Also known as: Metastin 45-54

Kisspeptin pump

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie B. Seminara, MD: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Study Coordinator

CONTACT

617-643-2308; MGHKisspeptinResearch@partners.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 4, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)