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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Interventions: Drug: Metformin; Drug: Ethinylestradiol and Cyproterone Acetate

• Registration Number: NCT01573377
• Lead Sponsor: Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-09
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-26
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metformin	Metformin	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.
Ethinylestradiol and Cyproterone Acetate	Ethinylestradiol and Cyproterone Acetate	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.

Primary Outcome Measures

Name	Time	Method
the efficacy of Metformin and Diane-35	at 12 weeks	Ovulation,Menstrual cycle,Insulin sensitivity

Secondary Outcome Measures

Name	Time	Method
changes of adipokine（PEDF,GPRN，etc）levels from baseline	at 12 weeks	changes of adipokine（PEDF,GPRN，etc）levels from baseline

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China