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Kisspeptin Administration Subcutaneously to Patients With IHH

RecruitingPhase 2

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Congenital IHH
* Confirmed diagnosis by medical provider supported by low sex steroids in the setting of low or inappropriately normal gonadotropins
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* No current or recent use of a medication 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 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 (not including marijuana)
* For women:
* Pregnant or trying to become pregnant
* Breast feeding
* History of: bilateral oophorectomy (both ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

About the study

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 is being tested

Sponsor: Stephanie B. Seminara, MD · Participants: 36 · Started: Feb 3, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05896293

Locations in the U.S.

MassachusettsMassachusetts General Hospital, Boston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.