Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05633966

Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Conditions: Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism

Sex: Female
Ages: 18 Years – 45 Years
Phase: PHASE1
Enrollment: 50
Sponsor: Stephanie B. Seminara, MD

Location: United States

Summary

The investigators 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.

Eligibility 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 administrationNo 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 administrationExclusion Criteria:Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocolHistory of a medication reaction requiring emergency medical careExcessive 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 belowPregnant or trying to become pregnantBreast feedingHistory of bilateral oophorectomy (ovaries were removed)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05633966). StuddyBuddy aggregates publicly available trial information.