A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Functional Hypothalamic Amenorrhea (FHA)
In brief
This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on patients with a condition called Functional Hypothalamic Amenorrhea (FHA). FHA is a condition where a woman stops menstruating because the brain is not sending the correct hormonal signals to the ovaries, which then are not able to cycle and ovulate properly. The aim of the study is to see how well the study drug helps the body make the hormones necessary for ovulation and reproduction, and to assess its safety. The study is looking at several other research questions, including: * Whether the drug helps bone health * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Key facts
- Study ID
- NCT07235917
- Run by
- Regeneron Pharmaceuticals
- People needed
- 34
- Starts
- 2026-03-11
- Expected to finish
- 2027-12-08
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Arensia Exploratory Medicine Clinic — Phoenix, Arizona, United States (enrolling)
- Focus Clinical Research — West Hills, California, United States (enrolling)
- Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
- Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
- Oregon Health and Science University (OHSU) — Portland, Oregon, United States (enrolling)
- OBGYN Associates of Erie — Erie, Pennsylvania, United States (enrolling)
- Penn State Health Milton South Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
- Zillan Clinical Research — Houston, Texas, United States (enrolling)
- University of Virginia School of Medicine — Charlottesville, Virginia, United States (enrolling)
- Tidewater Clinical Research - Tidewater Physicians for Women — Norfolk, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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