Mibavademab for adult women with functional hypothalamic amenorrhea
A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
This trial tests whether the experimental drug mibavademab helps adult women with functional hypothalamic amenorrhea make the hormones needed to resume ovulation and menstrual cycles.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | mibavademab |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Trial ID | NCT07235917 on ClinicalTrials.gov |
What this trial studies
Adult women with functional hypothalamic amenorrhea will receive either mibavademab or a matching placebo according to the phase 2 protocol. Investigators will measure hormone levels related to ovulation and menstruation, monitor menstrual bleeding, evaluate bone health markers, and collect safety, pharmacokinetic, and immunogenicity data. Key eligibility requires exclusion of anatomic or organic causes of amenorrhea and specific BMI/body‑fat criteria. The trial will track side effects and tolerability throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adult women diagnosed with functional hypothalamic amenorrhea who have had no menstrual bleeding for at least three months, meet the study's BMI and body‑fat criteria, and have had anatomic or organic causes excluded.
Not a fit: Patients with primary amenorrhea, screening estradiol ≥50 pg/mL or progesterone ≥1 ng/mL, structural uterine or ovarian conditions that affect menses, or other protocol exclusions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, mibavademab could help women with FHA resume ovulation and menstrual cycles and may also improve bone health.
How similar studies have performed: Hormone‑restoring approaches for FHA have shown mixed results in prior work and direct clinical data for mibavademab are limited, so this represents a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. 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 Key Exclusion Criteria: 1. 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
Where this trial is running
Phoenix, Arizona and 4 other locations
- Arensia Exploratory Medicine Clinic — Phoenix, Arizona, United States (Recruiting)
- Focus Clinical Research — West Hills, California, United States (Recruiting)
- OBGYN Associates of Erie — Erie, Pennsylvania, United States (Recruiting)
- Zillan Clinical Research — Houston, Texas, United States (Recruiting)
- Tidewater Clinical Research - Tidewater Physicians for Women — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.