Mibavademab for adult women with functional hypothalamic amenorrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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 \<23% from rigorous exercise as determined by the investigator through Standard of Care (SoC) methods (eg, skinfold thickness, DXA, bioimpedance) within 6 months of screening

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, as described in the protocol
3. Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian conditions (eg, absence of an ovary, presence of large polycystic ovaries i.e. greater than 10 cc) 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), as described in the protocol
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 it's running

• Arensia Exploratory Medicine Clinic
  Phoenix, Arizona, United States Recruiting
• Focus Clinical Research
  West Hills, California, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Oregon Health and Science University (OHSU)
  Portland, Oregon, United States Recruiting
• OBGYN Associates of Erie
  Erie, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Which form of estrogen best improves bone strength in women with functional hypothalamic amenorrhea?

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• Using romosozumab to improve bone density in women with functional hypothalamic amenorrhea

  This study is testing if a medication called romosozumab can help improve bone density in girls and women aged 14-25 who have low bone density due to functional hypothalamic amenorrhea.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.