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Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

NCT06170463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-12-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-03-01
Completion
2023-04-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06170463 on ClinicalTrials.gov