Skip to main content
OpenTrials
Completed

NCT Number: NCT06170463

Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age;
  • Residence;
  • level of education & type of work;
  • Marital and fertility statuses, and if infertility was the main complaint;
  • Presence of risk factors as sedentary lifestyle;
  • Emotional stress and family history of PCOS;
  • Obesity-related medical disorders especially DM or MAFLD;
  • History of previous treatment for PCOS and its outcomes;
  • Menstrual pattern such as infrequent menstrual periods.

Exclusion criteria

  • Women had other manifestations of metabolic syndrome:
  • Cardiac manifestations of PCOS;
  • Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
  • Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
  • Had morbid obesity with body mass index (BMI) >35 kg/m2;
  • Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.

Treatment and study plan

Metformin Hydrochloride

Drug

Met Group Received metformin hydrochloride 500 mg tab 3 times Daily

MI/DCI combination in 40:1 ratio

Drug

MI-group received MI/DCI combination in 40:1 ratio twice daily

Combination of Metformin hydrochloride and MI/DCI

Drug

MM Group Received both Met and MI Groups Treatment

Primary outcomes

  1. Improvement of mensural pattern

    Time frame: 6 months

    The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.