A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Not Applicable
Not yet recruiting
- Conditions
- Functional Hypothalamic Amenorrhea (FHA)
- Interventions
- Other: Placebo
- Registration Number
- NCT07235917
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 34
Inclusion Criteria
- Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea
- Has had no menstrual bleeding episode within 3 months (or longer) 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 <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
- 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
- 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
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mibavademab Mibavademab - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from the highest serum estradiol observed during a 28-day period Baseline to month 6
- Secondary Outcome Measures
Name Time Method Change from the mean serum estradiol observed during a 28-day period Baseline to month 6 Occurrence of menses followed by mid-cycle serum estradiol ≥200 pg/ml and mid-luteal serum progesterone ≥7.9 ng/ml At month 6 Change in the highest serum estradiol Baseline through 6 months Occurrence of serum estradiol ≥200 pg/ml Through 6 months Number of ovulatory menstrual cycles Through 6 months Number of menses with mid-luteal serum progesterone ≥7.9 ng/ml and midluteal estradiol ≥100 pg/ml Through 6 months Number of menstrual cycles Through 6 months Percent change in Bone Mineral Density (BMD) at the lumbar spine, as measured by Dual X-ray Absorptiometry (DXA) Baseline to 6 months Absolute change in BMD at the lumbar spine, as measured by DXA Baseline to 6 months Percent change in Bone Mineral Content (BMC) at the lumbar spine, as measured by DXA Baseline to 6 months Absolute change in BMC at the lumbar spine, as measured by DXA Baseline to 6 months Percent change in BMD at the lumbar spine, as measured by DXA in participants with baseline lumbar spine BMD Z-score <-1 Baseline to 6 months Absolute change in BMD at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score <-1 Baseline to 6 months Percent change in BMC at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score <-1 Baseline to 6 months Absolute change in BMC at the lumbar spine, as measured by DXA, in participants with baseline lumbar spine BMD Z-score <-1 Baseline to 6 months Occurrence of Treatment Emergent of Adverse Events (TEAEs) Up to day 280 Severity of TEAEs Up to day 280 Concentrations of total mibavademab in serum Up to day 280 Occurrence of Anti-Drug Antibodies (ADA) to mibavademab Up to day 280 Magnitude of ADA to mibavademab Up to day 280