Kisspeptin Administration Subcutaneously to Patients With Reproductive Disorders
The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
• 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