Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders (KASPR)
Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism
About this trial
This is an interventional other trial for Hypothalamic Amenorrhea focused on measuring Hypothalamic Amenorrhea, Hypogonadotropic Hypogonadism, Kisspeptin, GnRH
Eligibility Criteria
Inclusion Criteria: Acquired hypogonadotropic hypogonadism (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: Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal women 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 • 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)
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Kisspeptin pump
SC administration of kisspeptin for two weeks (pulsatile, every 90 minutes)