Clinical trial

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

Name
ZU-IRB#11195-21/6-2023
Description
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.
Trial arms
Trial start
2022-08-01
Estimated PCD
2023-03-01
Trial end
2023-04-15
Status
Completed
Phase
Early phase I
Treatment
Metformin Hydrochloride
Met Group Received metformin hydrochloride 500 mg tab 3 times Daily
Arms:
Met Group
MI/DCI combination in 40:1 ratio
MI-group received MI/DCI combination in 40:1 ratio twice daily
Arms:
MI Group
Combination of Metformin hydrochloride and MI/DCI
MM Group Received both Met and MI Groups Treatment
Arms:
MM Group
Size
210
Primary endpoint
Improvement of mensural pattern
6 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 210, 'type': 'ACTUAL'}}
Updated at
2023-12-20

1 organization

2 products

1 drug

1 indication

Organization
Zagazig University
Product
Metformin