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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT07235917

Public ClinicalTrials.gov record NCT07235917. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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)

Study identification

NCT ID
NCT07235917
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Regeneron Pharmaceuticals
Industry
Enrollment
34 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 40 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 10, 2026
Primary completion
Aug 19, 2027
Completion
Dec 7, 2027
Last update posted
Jul 13, 2026

2026 – 2027

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
10
Facility City State ZIP Site status
Arensia Exploratory Medicine Clinic Phoenix Arizona 85015 Recruiting
Focus Clinical Research West Hills California 91307 Recruiting
Yale University School of Medicine New Haven Connecticut 06510 Recruiting
Mayo Clinic Florida Jacksonville Florida 32224 Recruiting
Oregon Health and Science University (OHSU) Portland Oregon 97239 Recruiting
OBGYN Associates of Erie Erie Pennsylvania 16507 Recruiting
Penn State Health Milton South Hershey Medical Center Hershey Pennsylvania 17033 Recruiting
Zillan Clinical Research Houston Texas 77082 Recruiting
University of Virginia School of Medicine Charlottesville Virginia 22908 Recruiting
Tidewater Clinical Research - Tidewater Physicians for Women Norfolk Virginia 23502 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07235917, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 13, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07235917 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →