Kisspeptin Administration Subcutaneously to Patients With IHH

Assignment: All study subjects will undergo the same interventions.

Delivery of Interventions:

• Each subject will undergo a review of their medical history, physical exam, and screening laboratories.
• A single SC injection of leuprolide acetate may be administered approximately six days before kisspeptin administration. (Previously administration of Gonadotropin Releasing Hormone (GnRH) was used in this study.)
• A pelvic ultrasound will be performed on women 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 10 sessions, 70 minutes each)
• For women, undergo pelvic ultrasounds (approximately 4 sessions)
• Optional q10 min sampling up to 8 hours may take place before and after the course of kisspeptin

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)
• 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
• If applicable, willing to use birth control methods (as approved by a study medical professional) during the entire study and for one month after the last dose of study drug

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)
• Active use of illicit drugs (not including marijuana)
• For women:
• 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