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RECRUITING Phase 2

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

NCT07235917 · View on ClinicalTrials.gov ↗

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)

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

FieldValue
Enrollment Target 34 participants
Start Date 2026-03-31
Est. Completion 2027-12-08
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

290 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07235917 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Arizona, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07235917?

The interventions under investigation include: Placebo (OTHER), Mibavademab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07235917?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial