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Hypogonadotropic HypogonadismPeptides and GLP-1FertilityRare diseaseDrugPhase 2

What this study is

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

What's being tested

  • kisspeptin 112-121

    Intervention · DRUG

    SC administration of kisspeptin for two weeks (pulsatile, every 60-240 minutes)

  • leuprolide acetate

    Intervention · DRUG

    Single SC bolus

Study details

Official title
Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
Sponsor
Stephanie B. Seminara, MD
Conditions
Hypogonadotropic Hypogonadism
Enrolling
36 people
Starts
2023-02-03
Est. completion
2028-05
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗