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

Study Overview
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Brief Summary
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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 Title
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Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial

Conditions
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Polycystic Ovary Syndrome, Insulin Resistance

Intervention / Treatment
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* Drug: Metformin
* Drug: Ethinylestradiol and Cyproterone Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin<br>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. | Drug: Metformin<br>* 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.<br>* Other names: Glucophage;|
| Experimental: Ethinylestradiol and Cyproterone Acetate<br>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. | Drug: Ethinylestradiol and Cyproterone Acetate<br>* from the first day of bleeding of the menstrual cycle, daily oral administration of one pill for 21 days consecutively, then stopped taking the pill for seven days, and on the eighth day to start taking the pill again.<br>* Other names: Diane-35;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the efficacy of Metformin and Diane-35 | Ovulation,Menstrual cycle,Insulin sensitivity | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of adipokine（PEDF,GPRN，etc）levels from baseline | changes of adipokine（PEDF,GPRN，etc）levels from baseline | at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, insulin resistance