RecruitingPhase 2NCT05896293

Kisspeptin Administration Subcutaneously to Patients With IHH

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Sponsor

Stephanie B. Seminara, MD

Enrollment

36 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Hypogonadotropic Hypogonadism

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Congenital IHH
o 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

Exclusion Criteria6

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) and/or active use of illicit drugs
o Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation.
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

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.