Kisspeptin Administration Subcutaneously to Patients With IHH
ConditionHypogonadotropic Hypogonadism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
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 men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.
Funding Source: FDA OOPD
Eligibility criteria
Qualifiers
Congenital IHH
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
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) and/or active use of illicit drugs
Pregnant or trying to become pregnant
Breast feeding
Trial design
Treatments tested in this trial
- kisspeptin 112-121
- leuprolide acetate
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Stephanie B. Seminara, MD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Source ClinicalTrials.gov