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New treatment option for Functional Hypothalamic Amenorrhea (FHA)
Official title A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
ClinicalTrials.gov ID: NCT07235917
What this study is testing
What is Mibavademab?
Mibavademab is an investigational medicine, being studied as a potential treatment for functional hypothalamic amenorrhea (fha).
Also referred to as REGN4461.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- Diagnosis of FHA after exclusion of anatomic or organic causes of amenorrhea
- Has had no menstrual bleeding episode within 3 months (or longer) prior to day 1, as described in the protocol
- Has a Body Mass Index (BMI) ≥18.5 and \<25 kg/m\^2 at screening, or BMI ≥25 to \<30 kg/m\^2 at screening AND percentage of body fat \<20% from...
You likely can't join if
- Has presence of primary amenorrhea (failure to reach menarche, first menstrual cycle)
- Has blood estradiol ≥50 pg/mL or blood progesterone ≥1 ng/mL at screening
- Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian (eg, absence of an ovary, presence...
- Has conditions other than FHA that may cause amenorrhea or menstrual cycle disturbances (eg, polycystic ovarian syndrome, hyperprolactinemia, primary...
- Polycystic ovarian morphology with an ovarian volume \>10 cc on TransVaginal UltraSound (TVUS) [or TransAbdominal Pelvic Ultrasound (TAPU) if...
- Presence of follicle ≥17 mm, evidence of ruptured follicle, and/or evidence of corpus luteum on TVUS (or TAPU if applicable) at baseline NOTE: Other...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- West Hills, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Portland, Oregon, United States
- Erie, Pennsylvania, United States
- Hershey, Pennsylvania, United States
- Houston, Texas, United States
- Charlottesville, Virginia, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; West Hills, California, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Portland, Oregon, United States; Erie, Pennsylvania, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.