Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorStephanie B. Seminara, MD
About this trial
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.
Eligibility criteria
Qualifiers
Female
Ages 18-45 years
Acquired HH (hypothalamic amenorrhea, aka functional hypogonadotropic hypogonadism)
Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
Disqualifiers
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
Pregnant
Trial design
Treatments tested in this trial
- kisspeptin 112-121
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Stephanie B. Seminara, MD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov