A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
← catalyst calendarNCT07235917 · readout in 366 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
34estimated
Sites
10
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-11 | actual | When the study began enrolling |
| Primary completion | 2027-08-20 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-08 | estimated | The whole study's end, after follow-up |
| First posted | 2025-11-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Functional Hypothalamic Amenorrhea (FHA)
Interventions
- Drug: Mibavademab — also filed as REGN4461
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from the highest serum estradiol observed during a 28-day period
measured Baseline to month 6
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