A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorRegeneron Pharmaceuticals
About this trial
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)
Eligibility criteria
Qualifiers
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/m² at screening, or BMI ≥25 to <30 kg/m² 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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Mibavademab
- Placebo
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov