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

NCT ID: NCT01573377

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-02-28

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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome Insulin Resistance

Keywords

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polycystic ovary syndrome insulin resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Ethinylestradiol and Cyproterone Acetate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Ethinylestradiol and Cyproterone Acetate

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.

Intervention Type DRUG

Other Intervention Names

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Glucophage Diane-35

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifu Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qifu Li, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

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The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PCOS-Qifu Li

Identifier Type: -

Identifier Source: org_study_id