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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT07635082

NCT07635082
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • Women who have been diagnosed with polycystic ovary syndrome (PCOS) using a standard set of medical guidelines called the Rotterdam criteria.
  • Women whose PCOS has not responded to a fertility medication called letrozole — meaning they did not ovulate after taking letrozole (5 mg daily for 5 days) across three treatment cycles.
  • Women between the ages of 18 and 35 years old.
  • Women with a body mass index (BMI) of 30 or below (a measure of body weight relative to height).
  • Women whose uterus and fallopian tubes have been confirmed to be healthy and unblocked through specific medical tests.
  • Women whose male partner has had a normal sperm test.
  • Women who are willing and able to give their written agreement to take part in the trial.

Who may not be able to join:

  • Women who have a thyroid condition that affects how their thyroid gland works.
  • Women who have higher-than-normal levels of a hormone called prolactin.
  • Women who have diabetes.
  • Women who have a condition called congenital adrenal hyperplasia (a hormone disorder present from birth).
  • Women whose high androgen (male hormone) levels are caused by a problem with their adrenal glands.
  • Women who are taking medications that help the body use insulin more effectively, such as metformin, during the study period.
  • Women who have a long-term liver condition.
  • Women who have a long-term kidney condition.
  • Women who have any medical reason why pregnancy would not be safe for them (confirm with trial site).
  • Women who are allergic to, or have a medical reason not to take, either inositol or letrozole.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Eman Basuni Ebrahim Mowad
Registry
clinicaltrials_gov
Start date
1 February 2024
Est. completion
1 June 2025

Where this trial is recruiting

🇪🇬 Egypt

Primary endpoints

Ovulation Rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov