A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Purpose
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)
Condition
- Functional Hypothalamic Amenorrhea (FHA)
Eligibility
- Eligible Ages
- Between 18 Years and 40 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea 2. Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol 3. Has a Body Mass Index (BMI) ≥18.5 and <25 kg/m^2 at screening, or BMI ≥25 to <30 kg/m^2 at screening AND percentage of body fat <20% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening, as described in the protocol
Exclusion Criteria
- Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle) 2. Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening 3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence of polycystic ovaries) conditions that impact assessment of menses or of the HPO axis 4. Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary ovarian insufficiency, untreated primary hypothyroidism, primary hyperthyroidism) 5. Polycystic ovarian morphology with an ovarian volume >10 cc on TransVaginal UltraSound (TVUS) [or TransAbdominal Pelvic Ultrasound (TAPU) if applicable] at baseline 6. Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline NOTE: Other protocol-defined Inclusion/Exclusion criteria apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mibavademab |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Phoenix, Arizona 85015
West Hills, California 91307
Portland, Oregon 97239
Erie, Pennsylvania 16507
Houston, Texas 77082
Norfolk, Virginia 23502
More Details
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals