Finerenone for Premature Ovarian Insufficiency (POI)

Sponsor
The University of Hong Kong-Shenzhen Hospital
Study ID
NCT07815509
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Premature Ovarian Insufficiency

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.
  • Placebo — DRUG
    Matching placebo tablet, oral, administered twice weekly for 24 weeks.

Study Details

This study is testing whether finerenone, a medicine currently used to protect the kidneys and heart, can help women with premature ovarian insufficiency (POI) grow ovarian follicles and produce eggs that can be collected for in vitro fertilization (IVF). Women with POI often have very few or no active egg-containing follicles, making it hard for them to conceive. About 46 women with POI will be randomly assigned, without either the participants or their doctors knowing the assignment, to take either finerenone or a matching placebo twice weekly for 24 weeks. Participants will be monitored regularly with ultrasound and blood tests. If follicle growth is observed, participants may undergo ovarian stimulation so that eggs or embryos can be collected and frozen. The main goal is to see whether more women in the finerenone group have eggs successfully retrieved during an IVF cycle, compared with the placebo group. The study will also look at other measures of ovarian reserve, egg and embryo quality, and pregnancy outcomes among participants who go on to embryo transfer.

Key Dates

First listed
Sep 11, 2026
Start date
Sep 15, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Participants received oral finerenone 20 mg twice weekly for 24 weeks during the double-blind treatment phase.
  • Placebo Comparator: Placebo
    Participants received matching placebo tablets, oral, twice weekly for 24 weeks during the double-blind treatment phase.

Primary Outcome Measure

Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment [ Time Frame: Within 24 weeks of treatment initiation ]

Central Contacts

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