Kisspeptin Administration Subcutaneously to Patients With IHH

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Stephanie B. Seminara, MD
Study ID
NCT05896293
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Hypogonadotropic Hypogonadism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • kisspeptin 112-121 — DRUG
    SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)
  • leuprolide acetate — DRUG
    Single SC bolus

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 men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time. Funding Source: FDA OOPD

Key Dates

Start date
Feb 3, 2023
Status verified
Sep 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: kisspeptin pump
    SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes); administration of a single shot of leuprolide acetate (previously GnRH was used in this study)

Primary Outcome Measure

Average change in luteinizing hormone (LH) pulse amplitude [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Study Coordinator
[email protected]
617-726-1895

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies