Recruiting
Phase 2

Kisspeptin

Sponsor:

Stephanie B. Seminara, MD

Code:

NCT07224438

Conditions

Hypothalamic Amenorrhea

Hypogonadotropic Hypogonadism

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

kisspeptin 112-121

Study Details

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

Study ID

NCT07224438

Start date

Dec 9, 2025

Status verified date

Jul, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Kisspeptin pump

SC administration of kisspeptin for two weeks (pulsatile)

Interventions

kisspeptin 112-121

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

Primary outcome measure

  • Change of luteinizing hormone (LH) pulse amplitude [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Study Coordinator

617-643-2308MGHKisspeptinResearch@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

617-643-2308MGHKisspeptinResearch@partners.org

More Information

Sponsor

Stephanie B. Seminara, MD

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • hypothalamic amenorrhea
  • hypogonadotropic hypogonadism
  • kisspeptin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephanie B. Seminara, MD on 2026-07-13.