Completed

Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial

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What is being tested

Metformin

+ Ethinylestradiol and Cyproterone Acetate

Drug
Who is being recruted

Urogenital Diseases+15

+ Genital Diseases

+ Adnexal Diseases

From 18 to 35 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorChongqing Medical University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies in reproductive-age women, and it affects 5-7% of this group. It is characterized by disturbed menstrual cycle, ovulatory dysfunction and hyperandrogenism. Over 40% of PCOS women might become the patients with impaired glucose tolerance or type 2 diabetes. It has been confirmed that insulin resistance (IR) is a common feature in PCOS and adipokines might play roles in the pathogenesis of IR and PCOS, because these adipokines have wide-ranging effects on carbohydrate and lipid metabolism. The present clinical trial intends to compare the effects of metformin and oral contraceptives on PCOS patients, focusing on the insulin sensitivity, ovulation, and menstrual cycle etc. The investigators also aim to study the effects of metformin on serum adipokine levels(such as pigment epithelium-derived factor, progranulin etc.)in PCOS patients.

Official TitleEfficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
NCT01573377
Principal SponsorChongqing Medical University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersHyperinsulinismInsulin ResistanceMetabolic DiseasesNeoplasmsNutritional and Metabolic DiseasesOvarian CystsOvarian DiseasesPolycystic Ovary SyndromeGlucose Metabolism DisordersFemale Urogenital Diseases

Criteria

Inclusion Criteria: with at least two of the following features : (i) oligo-amenorrhea or chronic anovulation; (ii) clinical and/or biochemical hyperandrogenism; (iii) ultrasound appearance of polycystic ovaries Exclusion Criteria: \- other known causes of hyperandrogenemia and ovulatory dysfunction, including 21-hydroxylase deficiency, congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, thyroid disease, and hyperprolactinemia. use of hormone medications (including oral contraceptives) within the past month and the use of medicines that affect insulin sensitivity (e.g., metformin or thiazolidinediones) within the past three months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
425mg bid for morning and evening after meals, one week after treatment, increase the dosage to 850 mg bid. If the patients have side effects such as nausea, diarrhea and other gastrointestinal symptoms, the dose would be reduced to 425mg bid for 1 week, and try the dosage to 425mg tid again, until the maximum tolerated dose.

Group II

Experimental
From the first day of the menstruation, oral administration of one pill daily for 21 days consecutively, then discontinue using the pill for seven days, and on the eighth day, restart taking the pill.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital of Chongqing Medical University

Chongqing, ChinaOpen The First Affiliated Hospital of Chongqing Medical University in Google Maps
CompletedOne Study Center