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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01573377
First received: April 5, 2012
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Polycystic Ovary Syndrome
Insulin Resistance
Drug: Metformin
Drug: Ethinylestradiol and Cyproterone Acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chongqing Medical University:

Primary Outcome Measures:
  • the efficacy of Metformin and Diane-35 [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    Ovulation,Menstrual cycle,Insulin sensitivity


Secondary Outcome Measures:
  • changes of adipokine(PEDF,GPRN,etc)levels from baseline [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
    changes of adipokine(PEDF,GPRN,etc)levels from baseline


Enrollment: 40
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Glucophage
Experimental: 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.
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.
Other Name: Diane-35

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573377

Locations
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University
Investigators
Principal Investigator: Qifu Li, PhD The First Affiliated Hospital of Chongqing Medical University
  More Information

No publications provided

Responsible Party: Qifu Li, Professor, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT01573377     History of Changes
Other Study ID Numbers: PCOS-Qifu Li
Study First Received: April 5, 2012
Last Updated: December 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chongqing Medical University:
polycystic ovary syndrome
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Polycystic Ovary Syndrome
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Cyproterone
Cyproterone Acetate
Diane
Ethinyl Estradiol
Metformin
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Estrogens
Hormones

ClinicalTrials.gov processed this record on April 23, 2014