What is this study about and why is it being done?

We are seeking participants with a diagnosis of functional hypothalamic amenorrhea, also called FHA, for a clinical trial studying an investigational drug. You will be randomized (like the flip of a coin) into one of two groups: the group that receives the study medication, and the group that receives the placebo. The study drug is designed to work like leptin, a hormone in your body that helps control your metabolism and reproductive hormones. Overall, you will have 18 visits spanning up to 48 weeks. You first will have one enrollment visit, scheduled at your convenience, followed by weekly blood draws for 4 weeks. You will then return to our clinic every month for five months. About halfway through the study, you will repeat the 4 weekly blood draws at our clinic, before finishing the study with monthly visits for the next three months. Study procedures involve blood draws, physical exams, DXA scans (bone density testing), EKG tests (heart rhythm monitoring), and pelvic ultrasounds; not all procedures occur at every visit.

Please note that this clinical trial will use an investigational drug product, the safety and efficacy of which has not been fully evaluated by Regulatory Authorities and which has not received marketing authorization in any country.

Eligibility:

You may be eligible to participate in this study if you: 

• Have a diagnosis of functional hypothalamic amenorrhea, also called FHA
• Have not had a period in ~3 months 
• Are not currently pregnant or breastfeeding 
• Are 18 years of age or older
• Are not currently using hormonal birth control or a copper IUD

Please note there are additional study criteria to be eligible.

Compensation

You will be compensated for each of the study visits you complete.