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Women’s Health

Functional Hypothalamic Amenorrhea Clinical Trial for Hormonal Balance and Cycle Restoration

FHA Research

FHA Clinical Trial in Houston, TX

Functional hypothalamic amenorrhea (FHA) is a condition where menstrual periods stop due to disrupted hormonal signaling between the brain and reproductive system. It can affect ovulation, fertility, hormone balance, and bone health, and often persists despite standard care, highlighting the need for better treatment options.

Zillan Clinical Research is conducting a Phase II study evaluating an investigational treatment for women with FHA to understand its potential to restore hormonal balance, support the return of menstrual cycles, and improve ovulatory function under clinical supervision.

See Eligibility Criteria

About This Study

Advancing Care for Women’s Reproductive Health Through Hypothalamic Amenorrhea Research Study

For many women, missing menstrual cycles for an extended period (> 3 months) can be distressing and may impact fertility, emotional wellbeing, and overall reproductive health. In FHA, these changes are linked to disrupted hormonal signaling and may persist despite standard care.

The ongoing functional hypothalamic amenorrhea clinical trial is evaluating a study drug to assess its safety, tolerability and efficacy to help restore menstrual cycles, hormone balance, and improve overall reproductive health. Participation is voluntary and free of cost.

Now Enrolling

Current Status

Functional Hypothalamic Amenorrhea (FHA)

Condition
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FAQ

Frequently Asked Questions

The functional hypothalamic amenorrhea clinical trial is a Phase II study evaluating an investigational treatment (mibavademab/REGN4461) in women with FHA to assess safety and its potential effects on hormonal function and menstrual cycle recovery.

Yes. A functional hypothalamic amenorrhea clinical trial is currently being conducted at clinical research sites in Houston, TX to evaluate investigational treatment options for women diagnosed with FHA.

Women diagnosed with FHA who have not had a menstrual period for at least 3 months or longer may be eligible, subject to full medical screening and study criteria.

The study aims to evaluate whether the investigational treatment can help restore hormonal function, support menstrual cycles, improve ovulation-related hormone patterns, and assess safety.

Participants may receive either the investigational treatment or placebo and will attend scheduled visits for monitoring, hormone testing, and safety assessments.

Yes. The study is conducted under strict clinical guidelines. Participants are closely monitored by medical professionals throughout the study to track safety, side effects, and overall response to the investigational treatment.
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