Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

Study Overview
=================
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.

Official Title
-----------------
Effect of Dosage of Metformin on Menstruation and Lipid Profile in Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with PCOS Exclusion Criteria: avoiding to participate in the study
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lower metformin dose group<br>500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks | Drug: Metformin<br>* 500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks<br>* Other names: metformex;|
| Active Comparator: Higher metformin dose group<br>500 mg metfomin 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 | Drug: Metformin<br>* 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<br>* Other names: metformex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile | The serum levels of Cholesterol, LDL, HDL and Triglyceride were measured before and after of treatment in both groups. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone levels | LH, FSH, Testosterone | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polycystic ovary syndrome, lipid profile, metformin