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

Official title

A Phase 2, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea

Overview

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)

Interventions

• Drug Mibavademab
  Administered per the protocol
• Other Placebo
  Administered per the protocol

Primary outcome measures

• Change from the highest serum estradiol observed during a 28-day period [Time frame: Baseline to month 6]

Secondary outcome measures (12)

• Change from the mean serum estradiol observed during a 28-day period [Time frame: 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 [Time frame: At month 6]
• Change in the highest serum estradiol [Time frame: Baseline through 6 months]
• Occurrence of serum estradiol ≥200 pg/ml [Time frame: Through 6 months]
• Number of ovulatory menstrual cycles [Time frame: Through 6 months]
• Number of menses with mid-luteal serum progesterone ≥7.9 ng/ml and midluteal estradiol ≥100 pg/ml [Time frame: Through 6 months]
• Number of menstrual cycles [Time frame: Through 6 months]
• Percent change in Bone Mineral Density (BMD) at the lumbar spine, as measured by Dual X-ray Absorptiometry (DXA) [Time frame: Baseline to 6 months]
• Absolute change in BMD at the lumbar spine, as measured by DXA [Time frame: Baseline to 6 months]
• Percent change in Bone Mineral Content (BMC) at the lumbar spine, as measured by DXA [Time frame: Baseline to 6 months]
• Absolute change in BMC at the lumbar spine, as measured by DXA [Time frame: 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 [Time frame: Baseline to 6 months]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 10 centers

• Arensia Exploratory Medicine Clinic — Phoenix
• Focus Clinical Research — West Hills
• Yale University School of Medicine — New Haven
• Mayo Clinic Florida — Jacksonville
• Oregon Health and Science University (OHSU) — Portland
• OBGYN Associates of Erie — Erie
• Penn State Health Milton South Hershey Medical Center — Hershey
• Zillan Clinical Research — Houston
• … and 2 more centers

Identifiers

NCT: NCT07235917 · R4461-FHA-2485

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗