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RecruitingPhase 2

A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea

Regeneron Pharmaceuticals · NCT07235917

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–40 · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
34
US sites recruiting
10
Study start
March 11, 2026
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

This study is researching an experimental drug called mibavademab (also called "study drug"). The study is focused on participants 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 study drug less effective or could lead to side effects)

Being studied: Mibavademab; Placebo

Conditions: Functional Hypothalamic Amenorrhea; FHA

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea
  • Has had no menstrual bleeding episode within 3 months prior to day 1, as described in the protocol
  • 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

  • Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle)
  • Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening, as described in the protocol
  • 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
  • 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
  • Polycystic ovarian morphology with an ovarian volume >10 cc on TransVaginal UltraSound (TVUS) [or TransAbdominal Pelvic Ultrasound (TAPU) if applicable] at baseline
  • 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

Recruiting US locations

Study contacts (from the official record)

  • Clinical Trials Administrator · 844-734-6643 · clinicaltrials@regeneron.com
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A Study to Investigate Mibavademab in Adult Women With Functional… (NCT07235917) | Bored Studies