Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients
Recruiting
Phase 3Interventional Study
Poly Cystic Ovary Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 40
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Beni-Suef University · Other
Who this trial is looking for
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This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Women aged 21 to 40 years
* Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
* Not currently pregnant or lactating
* No hormonal therapy within the last 3 months
* Willing and able to provide informed consent
Exclusion Criteria:
* \- History of…
Inclusion Criteria:
* Women aged 21 to 40 years
* Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
* Not currently pregnant or lactating
* No hormonal therapy within the last 3 months
* Willing and able to provide informed consent
Exclusion Criteria:
* \- History of diabetes mellitus, hypertension, or thyroid disorders
* History of cardiovascular, renal, or hepatic disease
* Use of hormonal contraceptives or insulin sensitizers within the last 3 months
* Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)
* Non-Egyptian ethnicity
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