Actively Recruiting
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Led by Regeneron Pharmaceuticals · Updated on 2026-04-29
34
Participants Needed
5
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Functional Hypothalamic Amenorrhea (FHA) after excluding anatomical or organic causes of amenorrhea
- No menstrual bleeding for at least 3 months before study start
- Body Mass Index (BMI) between 18.5 and less than 25 kg/m2 at screening, or BMI between 25 and less than 30 kg/m2 with body fat less than 20% from exercise within 6 months of screening
You will not qualify if you...
- Primary amenorrhea (never had first menstrual cycle)
- Blood estradiol 50 pg/mL or higher or blood progesterone 1 ng/mL or higher at screening
- Uterine or ovarian conditions affecting assessment of menstrual cycle or hormone axis (e.g., absence of uterus or ovary, endometrial ablation, endometriosis, polycystic ovaries)
- Conditions other than FHA causing amenorrhea or menstrual cycle disturbances (e.g., polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated thyroid disorders)
- Polycystic ovarian morphology with ovarian volume greater than 10 cc on ultrasound at baseline
- Presence of follicle 17 mm or larger, ruptured follicle, or corpus luteum on ultrasound at baseline
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Arensia Exploratory Medicine Clinic
Phoenix, Arizona, United States, 85015
Actively Recruiting
2
Focus Clinical Research
West Hills, California, United States, 91307
Actively Recruiting
3
OBGYN Associates of Erie
Erie, Pennsylvania, United States, 16507
Actively Recruiting
4
Zillan Clinical Research
Houston, Texas, United States, 77082
Actively Recruiting
5
Tidewater Clinical Research - Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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