ClinicalTrials.gg
Not yet recruitingNCT07815509Updated Sep 11, 2026

Finerenone for Premature Ovarian Insufficiency (POI)

A Phase 2 interventional study of Finerenone and Placebo in Premature Ovarian Insufficiency, sponsored by The University of Hong Kong-Shenzhen Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by The University of Hong Kong-Shenzhen Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Premature Ovarian Insufficiency

Keywords

  • Finerenone
  • Ovarian Reserve
  • In Vitro Fertilization
  • Antral Follicle Count
  • Premature Ovarian Insufficiency
03

In context

Primary Ovarian Insufficiency

181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.

This study's planned enrollment of 46 is close to the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.

Browse Primary Ovarian Insufficiency studies →

Lead sponsor

The University of Hong Kong-Shenzhen Hospital is the lead sponsor of 16 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Known to Finerenone or any of its .
  • Severe uncontrolled systemic diseases (cardiovascular, hepatic, renal, or endocrine disorders) that may interfere with study participation.
  • Active or history of hormone-dependent cancer.
  • Currently participating in another interventional trial.
  • Known chromosomal abnormalities or genetic syndromes associated with POI.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Finerenone

    Participants received oral finerenone 20 mg twice weekly for 24 weeks during the double-blind treatment phase.

    Drug: Finerenone

  • Placebo comparator
    Placebo

    Participants received matching placebo tablets, oral, twice weekly for 24 weeks during the double-blind treatment phase.

    Drug: Placebo

Interventions

  • Finerenone 20 mg oral tablet, administered twice weekly for 24 weeks.

  • DrugPlacebo

    Matching placebo tablet, oral, administered twice weekly for 24 weeks.

06

What researchers measure

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.

    Time frame: Within 24 weeks of treatment initiation

Secondary outcomes

  1. Antral Follicle Count (AFC)

    Change in antral follicle count (AFC) measured by ultrasound from baseline, assessed during follow-up visits.

    Time frame: Baseline and every 4 weeks up to 24 weeks of treatment

  2. Anti-Mullerian Hormone (AMH)

    Change in serum Anti-Mullerian Hormone (AMH) level from baseline, assessed during follow-up visits.

    Time frame: Baseline and every 4 weeks up to 24 weeks of treatment

  3. Serum Estradiol (E2) Level on Trigger Day

    Serum estradiol (E2) level measured on the day of ovulation trigger during follicular development monitoring.

    Time frame: On the day of ovulation trigger, within 24 weeks of treatment

  4. Number of Total and Mature Oocytes Retrieved

    Number of total oocytes and number of mature (MII) oocytes retrieved during IVF oocyte retrieval.

    Time frame: At oocyte retrieval, within 24 weeks of treatment

  5. Fertilization Rate

    Proportion of retrieved oocytes that are successfully fertilized during IVF.

    Time frame: Within 24 weeks of treatment initiation

  6. Number of Embryos Formed

    Number of embryos formed following fertilization of retrieved oocytes.

    Time frame: Within 24 weeks of treatment initiation

  7. Blastocyst Development Rate / High-Quality Embryo Rate

    Proportion of embryos developing to blastocyst stage and/or classified as high-quality embryos.

    Time frame: Within 24 weeks of treatment initiation

  8. Clinical Pregnancy Rate

    Proportion of participants with ultrasound-confirmed intrauterine gestational sac at approximately 6-7 weeks of gestation following embryo transfer.

    Time frame: Approximately 6-7 weeks of gestation

  9. Ongoing Pregnancy Rate

    Proportion of participants with fetal cardiac activity confirmed by ultrasound at 8-10 weeks of gestation.

    Time frame: 8-10 weeks of gestation

  10. Live Birth Rate

    Proportion of participants with delivery at or beyond 24 weeks gestation.

    Time frame: At delivery (approximately 24-40 weeks gestation)

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07815509
Lead sponsor
The University of Hong Kong-Shenzhen Hospital
Responsible party
Tianren Wang (Clinical Assistant Professor, The University of Hong Kong-Shenzhen Hospital) — Principal investigator
First posted
Sep 11, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Tianren Wang
Contact
wangtr@hku.hk
+85222554684

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Finerenone

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