Finerenone for Premature Ovarian Insufficiency (POI)
A Randomized, Double-Blind, Placebo-Controlled Trial of Finerenone in Women With Premature Ovarian Insufficiency
2 other identifiers
interventional
46
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2026
CompletedFirst Posted
Study publicly available on registry
September 11, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
September 11, 2026
September 1, 2026
1.2 years
September 3, 2026
September 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment
The proportion of participants who have oocytes aspirated during in vitro fertilization (IVF) within 24 weeks of starting study treatment.
Within 24 weeks of treatment initiation
Secondary Outcomes (10)
Antral Follicle Count (AFC)
Baseline and every 4 weeks up to 24 weeks of treatment
Anti-Mullerian Hormone (AMH)
Baseline and every 4 weeks up to 24 weeks of treatment
Serum Estradiol (E2) Level on Trigger Day
On the day of ovulation trigger, within 24 weeks of treatment
Number of Total and Mature Oocytes Retrieved
At oocyte retrieval, within 24 weeks of treatment
Fertilization Rate
Within 24 weeks of treatment initiation
- +5 more secondary outcomes
Study Arms (2)
Finerenone
EXPERIMENTALParticipants received oral finerenone 20 mg twice weekly for 24 weeks during the double-blind treatment phase.
Placebo
PLACEBO COMPARATORParticipants received matching placebo tablets, oral, twice weekly for 24 weeks during the double-blind treatment phase.
Interventions
Eligibility Criteria
You may qualify if:
- Age of women \<40 years.
- Diagnosis of POI according to ESHRE 2024 guidelines, defined as:
- Oligomenorrhea or amenorrhea for at least 4 months; and
- Elevated FSH levels (≥25 mIU/mL) on a single measurement.
You may not qualify if:
- Known hypersensitivity to Finerenone or any of its excipients.
- Severe uncontrolled systemic diseases (cardiovascular, hepatic, renal, or endocrine disorders) that may interfere with study participation.
- Active malignancy or history of hormone-dependent cancer.
- Currently participating in another interventional trial.
- Known chromosomal abnormalities or clinically significant genetic syndromes associated with POI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
September 3, 2026
First Posted
September 11, 2026
Study Start
September 15, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
September 11, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Start: 12 months after publication of the primary results End: No end date
- Access Criteria
- Qualified researchers + scientifically sound research + reasonable request + investigator/institutional review + ethical/privacy requirements
De-identified individual participant data collected during the study, including baseline characteristics, treatment allocation, ovarian reserve and ovarian function measures, treatment outcomes, and safety data, may be shared with qualified researchers upon reasonable request, subject to applicable ethical and data protection requirements.