Kisspeptin Administration Subcutaneously to Patients With IHH

• Status: Recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

We are recruiting men and women with Idiopathic Hypogonadotropic Hypogonadism (IHH). Kisspeptin will be administered subcutaneously (SC) for 2-weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (q10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephanie B. Seminara, MD

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)

• Not using hormonal replacement or willing to complete an appropriate washout for that particular medication and method of administration

• 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 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

• History of a medication reaction requiring emergency medical care

• Excessive alcohol consumption (>10 drinks/week) and/or active use of illicit drugs

· Any active use of marijuana will be evaluated by a study medical professional to determine if it may impact study participation. Individuals who regularly use marijuana may be asked to washout as referenced in the medication washout section below.

• Pregnant or trying to become pregnant

• Breast feeding

• History of bilateral oophorectomy (ovaries were removed)