Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephanie B. Seminara, MD

Criteria

Inclusion Criteria:

• Congenital IHH or acquired HH (hypothalamic amenorrhea, aka functional hypothalamic amenorrhea) [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)

• Laboratory Studies: 1)Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women 2) Negative serum hCG pregnancy test at screening (additional urine pregnancy test will be conducted prior to drug administration)

• 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 1) 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)