NCT06170463

Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

Combined Insulin Sensitizers as Double-Weapon to Detonate PCOS-induced Vicious Circle

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.

Conditions

• PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Interventions

Type	Name	Description
DRUG	Metformin Hydrochloride	Met Group Received metformin hydrochloride 500 mg tab 3 times Daily
DRUG	MI/DCI combination in 40:1 ratio	MI-group received MI/DCI combination in 40:1 ratio twice daily
DRUG	Combination of Metformin hydrochloride and MI/DCI	MM Group Received both Met and MI Groups Treatment

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-03-01
• Completion: 2023-04-15
• First posted: 2023-12-14
• Last updated: 2023-12-20

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study