Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Stephanie B. Seminara, MD
Study ID
NCT07224438
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hypogonadotropic Hypogonadism
  • Hypothalamic Amenorrhea

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • kisspeptin 112-121 — DRUG
    SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes)

Study Details

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.

Key Dates

Start date
Dec 9, 2025
Status verified
Dec 2025
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Kisspeptin pump
    SC administration of kisspeptin for two weeks (pulsatile)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Study Coordinator
[email protected]
617-643-2308

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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