Health TrialsbyHealthPanel

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

ConditionsFunctional Hypothalamic AmenorrheaFHA
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 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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m² at screening, or BMI ≥25 to <30 kg/m² 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

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, 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mibavademab

    Drug

    Administered per the protocol

  • Placebo

    Other intervention

    Administered per the protocol

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: MibavademabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from the highest serum estradiol observed during a 28-day period

Time frame
Baseline to month 6

Secondary outcomes

1

Change from the mean serum estradiol observed during a 28-day period

Time frame
Baseline to month 6
2

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
3

Change in the highest serum estradiol

Time frame
Baseline through 6 months
4

Occurrence of serum estradiol ≥200 pg/ml

Time frame
Through 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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