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

Conditions

• Functional Hypothalamic Amenorrhea (FHA)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• Mibavademab — DRUG
  Administered per the protocol
• Placebo — OTHER
  Administered per the protocol

Study Details

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)

Key Dates

Start date

Mar 11, 2026

Status verified

May 2026

Primary completion

Aug 20, 2027

Completion

Dec 8, 2027

Study Design

Enrollment

34 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mibavademab
• Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (6)

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