Kisspeptin Administration Subcutaneously to Patients With Hypothalamic Amenorrhea
Recruiting
Phase 2
Interventional Study
Hypothalamic Amenorrhea
Hypogonadotropic Hypogonadism
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Stephanie B. Seminara, MD · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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)
* Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for normal …
Contacts