Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

NCT06170463 | Completed Phase 1 FDA Drug

• 1 other identifier: ZU-IRB#11195-21/6-2023
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Improvement of mensural pattern

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

  6 months

Study Arms (3)

Met Group

ACTIVE COMPARATOR

Drug: Metformin Hydrochloride

MI Group

ACTIVE COMPARATOR

Drug: MI/DCI combination in 40:1 ratio

MM Group

ACTIVE COMPARATOR

Drug: Combination of Metformin hydrochloride and MI/DCI

Interventions

Metformin Hydrochloride DRUG

Met Group Received metformin hydrochloride 500 mg tab 3 times Daily

Met Group

MI/DCI combination in 40:1 ratio DRUG

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

MI Group

Combination of Metformin hydrochloride and MI/DCI DRUG

MM Group Received both Met and MI Groups Treatment

MM Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Ash Sharqia Governorate, 44519, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of gynecology

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 15, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

EG (1)