Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07235917 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
A Phase 2 study of Functional Hypothalamic Amenorrhea (FHA), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 5
- Study locations
NCT07235917 is a Phase 2 study of Functional Hypothalamic Amenorrhea (FHA) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 34 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT07235917, a Phase 2 study of Functional Hypothalamic Amenorrhea (FHA), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 5
- Study locations
Study Summary
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)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Mibavademab
Study Locations (5)
Arizona
- Arensia Exploratory Medicine Clinic - Phoenix
California
- Focus Clinical Research - West Hills
Pennsylvania
- OBGYN Associates of Erie - Erie
Texas
- Zillan Clinical Research - Houston
Virginia
- Tidewater Clinical Research - Tidewater Physicians for Women - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2027-12-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07235917
The ClinicalTrials.gov registry entry for NCT07235917 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Functional Hypothalamic Amenorrhea (FHA) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07235917 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Arizona, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07235917 about?
NCT07235917 is a clinical study titled "A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea". 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 s...
What is the current status of trial NCT07235917?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2026-03-31. Estimated completion is 2027-12-08.
What conditions does trial NCT07235917 study?
This clinical trial studies the following conditions: Functional Hypothalamic Amenorrhea (FHA).
What interventions are being tested in trial NCT07235917?
The interventions under investigation include: Placebo (OTHER), Mibavademab (DRUG).
Who is sponsoring clinical trial NCT07235917?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07235917 being conducted?
This trial has 5 study locations across Arizona, California, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.