Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

• The subject will undergo a review of their medical history, physical exam, and screening laboratories.
• A pelvic ultrasound will be performed to assess baseline follicular size.
• A pump will be placed to administer pulsatile SC kisspeptin for two weeks.
• During the course of kisspeptin administration, subjects will

• Undergo q10 min blood sampling (approximately 4 sessions, 2 hours each)
• Undergo pelvic ultrasounds (approximately 4 sessions)
• Optional q10 min sampling up to 10 hours may take place before and after the course of kisspeptin

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)
• 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
• 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.
• 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