Functional Hypothalamic Amenorrhea study: Mibavademab
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 (REGN4461)?
An investigational injectable medicine being studied for Functional Hypothalamic Amenorrhea.
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 testing whether mibavademab can help your body make the hormones needed for ovulation and reproduction. It also looks at bone health, side effects, and how the drug behaves in your blood.
- Who it's for
- You may be able to join if you are an adult woman with Functional Hypothalamic Amenorrhea.
- What's involved
- You would receive the study drug and have regular visits for blood tests and health checks. The visits will track hormone levels, bone health, and any side effects.
- Time commitment
- The study lasts about 6 months, with several clinic visits over that time.
- 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 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 \<23% 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, as described in the protocol
- Has uterine (eg, absence of uterus, prior endometrial ablation, endometriosis, outflow tract disorders) or ovarian conditions (eg, absence of an...
- 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 is enrolling
- 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
- Philadelphia, Pennsylvania, 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.