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Mibavademab · KYRIAD

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

Ensayo de REGENERON PHARMACEUTICALS, INC. en Functional Hypothalamic Amenorrhea (FHA) (del registro, en inglés).

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

34

previstos

Centros

10

Fin del objetivo primario

ago 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2026.

Qué mide

Change from the highest serum estradiol observed during a 28-day period (del registro, en inglés) (del inicio al mes 6)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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)

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07235917), actualizada en jul 2026.