Premature Ovarian InsufficiencyPhase 2NCT07815509
Finerenone for Premature Ovarian Insufficiency (POI)
A Phase 2 study testing Finerenone in people with Premature Ovarian Insufficiency, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2026to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, 518000
Tianren Wang, +85222554684, wtrcmu@126.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Finerenone in Women With Premature Ovarian Insufficiency
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.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- Finerenone, Placebo
- Keywords
- Finerenone, Ovarian Reserve, In Vitro Fertilization, Antral Follicle Count, Premature Ovarian Insufficiency
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.
PlaceboDrug
Matching placebo tablet, oral, administered twice weekly for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Participants received oral finerenone 20 mg twice weekly for 24 weeks during the double-blind treatment phase. Receives: Drug: Finerenone |
| Placebo | Placebo comparator | Participants received matching placebo tablets, oral, twice weekly for 24 weeks during the double-blind treatment phase. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 weeks of treatment initiation
Secondary outcomes (10)
Antral Follicle Count (AFC)
Change in antral follicle count (AFC) measured by ultrasound from baseline, assessed during follow-up visits.
Measured: Baseline and every 4 weeks up to 24 weeks of treatment
Anti-Mullerian Hormone (AMH)
Change in serum Anti-Mullerian Hormone (AMH) level from baseline, assessed during follow-up visits.
Measured: Baseline and every 4 weeks up to 24 weeks of treatment
Serum Estradiol (E2) Level on Trigger Day
Serum estradiol (E2) level measured on the day of ovulation trigger during follicular development monitoring.
Measured: On the day of ovulation trigger, within 24 weeks of treatment
Number of Total and Mature Oocytes Retrieved
Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval.
Measured: At oocyte retrieval, within 24 weeks of treatment
Fertilization Rate
Proportion of retrieved oocytes that are successfully fertilized during IVF.
Measured: Within 24 weeks of treatment initiation
Number of Embryos Formed
Number of embryos formed following fertilization of retrieved oocytes.
Measured: Within 24 weeks of treatment initiation
Blastocyst Development Rate / High-Quality Embryo Rate
Proportion of embryos developing to blastocyst stage and/or classified as high-quality embryos.
Measured: Within 24 weeks of treatment initiation
Clinical Pregnancy Rate
Proportion of participants with ultrasound-confirmed intrauterine gestational sac at approximately 6-7 weeks of gestation following embryo transfer.
Measured: Approximately 6-7 weeks of gestation
Ongoing Pregnancy Rate
Proportion of participants with fetal cardiac activity confirmed by ultrasound at 8-10 weeks of gestation.
Measured: 8-10 weeks of gestation
Live Birth Rate
Proportion of participants with delivery at or beyond 24 weeks gestation.
Measured: At delivery (approximately 24-40 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianren Wang, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815509
- Sponsor's protocol ID
- hkuszh2026127
- Other IDs
- IRB[2026]204
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Finerenone in Women With Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT07815509
- Acronym / sponsor ID
- hkuszh2026127
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Finerenone, Ovarian Reserve, In Vitro Fertilization, Antral Follicle Count, Premature Ovarian Insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: FinerenoneParticipants received oral finerenone 20 mg twice weekly for 24 weeks during the double-blind treatment phase. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo tablets, oral, twice weekly for 24 weeks during the double-blind treatment phase. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneFinerenone 20 mg oral tablet, administered twice weekly for 24 weeks. | Drug | Finerenone |
| PlaceboMatching placebo tablet, oral, administered twice weekly for 24 weeks. | Drug | Placebo |
Primary outcome
Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment
Time frame: Within 24 weeks of treatment initiation
The proportion of participants who have oocytes aspirated during in vitro fertilization (IVF) within 24 weeks of starting study treatment.
10 secondary outcomes
Antral Follicle Count (AFC)
Time frame: Baseline and every 4 weeks up to 24 weeks of treatment
Anti-Mullerian Hormone (AMH)
Time frame: Baseline and every 4 weeks up to 24 weeks of treatment
Serum Estradiol (E2) Level on Trigger Day
Time frame: On the day of ovulation trigger, within 24 weeks of treatment
Number of Total and Mature Oocytes Retrieved
Time frame: At oocyte retrieval, within 24 weeks of treatment
Fertilization Rate
Time frame: Within 24 weeks of treatment initiation
Number of Embryos Formed
Time frame: Within 24 weeks of treatment initiation
Blastocyst Development Rate / High-Quality Embryo Rate
Time frame: Within 24 weeks of treatment initiation
Clinical Pregnancy Rate
Time frame: Approximately 6-7 weeks of gestation
Ongoing Pregnancy Rate
Time frame: 8-10 weeks of gestation
Live Birth Rate
Time frame: At delivery (approximately 24-40 weeks gestation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Finerenone in people with Premature Ovarian Insufficiency, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianren Wang (+85222554684, wangtr@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Oocytes Retrieved During IVF Within 24 Weeks of Treatment (time frame: Within 24 weeks of treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.