A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome
Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Egypt
Faculty of Medicine, Cairo University
RECRUITING
Cairo
Contact Information
Primary
Ahmed A Abdelkader, Lecturer Assistant
ahmed.abdelkader@hu.edu.eg
+201050095206
Backup
Marwa Mohsen Mahmoud, Lecturer
Marwa.Mohsen@pharm.bsu.edu.eg
+201202203223
Time Frame
Start Date: 2026-03-10
Estimated Completion Date: 2026-12
Participants
Target number of participants: 180
Treatments
Experimental: Myo-Inositol + Folic Acid
Participants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months.
Experimental: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid
Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily for 6 months.
Experimental: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin
Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily and metformin titrated up to 1500 mg/day over 2 weeks for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Beni-Suef University