Efficacy of Metformin and Diane-35 on PCOS Patients,a Randomized, Controlled, Prospective Clinical Trial
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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 |
- the efficacy of Metformin and Diane-35 [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]Ovulation,Menstrual cycle,Insulin sensitivity
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | October 2012 (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 |
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| Contact: Qifu Li, PhD | +86 23 89011510 | liqifu@yeah.net |
| China, Chongqing | |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting |
| Chongqing, Chongqing, China, 400016 | |
| Sub-Investigator: Shumin Yang, PhD | |
| 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: | April 6, 2012 |
| 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 June 13, 2013