Insulin Sensitizers Role in Control of PCOS Vicious Cycle.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06170463

Enrollment

210

Registered

2023-12-14

Start date

2022-08-01

Completion date

2023-04-15

Last updated

2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

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.

Interventions

DRUGMetformin Hydrochloride

Met Group Received metformin hydrochloride 500 mg tab 3 times Daily

DRUGMI/DCI combination in 40:1 ratio

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

DRUGCombination of Metformin hydrochloride and MI/DCI

MM Group Received both Met and MI Groups Treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Improvement of mensural pattern	6 months	The Evaluation of the success rate of the applied regimens to gain mensural regular pattern in PCOS Women

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026