Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome
Overview[ - collapse ][ - ]
| Purpose | Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this study was to assess the effects of metformin on menstrual disorders and lipid profile in women with PCOS in bandarabbas. |
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| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Drug: Metformin |
| Phase | N/A |
| Sponsor | Hormozgan University of Medical Sciences |
| Responsible Party | Hormozgan University of Medical Sciences |
| ClinicalTrials.gov Identifier | NCT01474967 |
| First Received | November 16, 2011 |
| Last Updated | November 18, 2011 |
| Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 16, 2011 |
|---|---|
| Last Updated Date | November 18, 2011 |
| Start Date | February 2010 |
| Estimated Primary Completion Date | February 2011 |
| Current Primary Outcome Measures | Lipid profile [Time Frame: 6 month] [Designated as safety issue: No]The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups. |
| Current Secondary Outcome Measures | Hormone levels [Time Frame: 6 month] [Designated as safety issue: No]LH, FSH, Testosterone |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome |
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| Official Title | Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome |
| Brief Summary | Polycystic ovarian syndrome (PCOS) is the most common cause of anovulatory infertility and causes menstrual disruption in 6.6-6.8% of women in reproductive age and is characterized by insulin resistance, hyperinsulinemia, hyperandrogenism and anovulation. The gaol of this study was to assess the effects of metformin on menstrual disorders and lipid profile in women with PCOS in bandarabbas. |
| Detailed Description | Poly cystic ovarian syndrome (PCOS) is a common hormonal disorder in women that affecting of 6.6-6.8% of women o f reproductive age. PCOS associated with a broad range of clinical, hormonal and metabolic disorders consist of hirsutism, Obesity, Acne and elevated male hormones, anovulatory cycles, dyslipidemia and infertility. Metformin is an oral hyperglycemic agent witch by decrease insulin resistance and improving serum glucose level in diabetic patients and anovulatory cyle in women with PCOS. The goal of this study is to evaluate the efficacy of different dosage of metformin on menstruation and lipid profile in women with PCOS in banda-abbas. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin 500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 1 week 500 mg metformin with breakfast and 1000 mg with dinner for 22 weeks Other Names: metformexDrug: Metformin 500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks Other Names: metformex |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | February 2011 |
| Estimated Primary Completion Date | January 2011 |
| Eligibility Criteria | Inclusion Criteria: - Women with PCOS Exclusion Criteria: - avoiding to participate in the study |
| Gender | Female |
| Ages | N/A |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Iran, Islamic Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01474967 |
|---|---|
| Other Study ID Numbers | Metformin in PCOS |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Hormozgan University of Medical Sciences |
| Study Sponsor | Hormozgan University of Medical Sciences |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Nazanin Abdi, resident Hormozgan University of Medical Sciences (HUMS) |
| Verification Date | November 2011 |
Locations[ + expand ][ + ]
| Hormozgan University of Medical Sciences (HUMS) | Bandarabbas, Hormozgan, Iran, Islamic Republic of, 791451692 |
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