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The aim of this study is to evaluate the effects of three-month course of treatment modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine and high sensitive C-reactive protein (hs-CRP)] levels.
Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive age, making it one of the most common endocrine disorders in this population. PCOS is associated with a broad range of adverse sequel, including hypertension, dyslipidemia, insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized as a component of the metabolic syndrome. Management depends on symptoms or the source of androgen excess. Several treatment options are available, which allows for an individualized approach. Spironolactone is the safest potent available antiandrogen. It is effective in lowering the hirsutism score by approximately one third, although considerable individual variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase insulin sensitivity, but their mechanism of action differ.
Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be linked with insulin resistance.
The investigators want to measure serum complement, homocysteine and hs-CRP levels in patients with PCOS before and after three-month course of treatment with Cyproterone compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyproterone compound + Spironolactone | Active Comparator | Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily |
|
| Metformin | Active Comparator | Metformin 1500 mg daily |
|
| Pioglitazone | Active Comparator | Pioglitazone 30 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyproterone compound + Spironolactone | Drug | Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum C3 level | Serum concentration of a component of complement cascade: C3 | 3 months |
| Serum C4 level | Serum concentration of a component of complement cascade: C4 | 3 months |
| Serum high-sensitive CRP (C-reactive protein) | Serum concentration of high-sensitive C-reactive protein (hs-CRP) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum total Testosterone level | Serum concentration of total Testosterone | 3 months |
| Serum free Testosterone level | Serum concentration of free Testosterone |
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Inclusion Criteria:
Age 18-35 years
Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mesbah Shams, MD | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Principal Investigator |
| Gholamhossein R Omrani, MD | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Motahhari Clinic, Shiraz University of Medical Sciences | Shiraz | Fars | Iran |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
| Metformin | Drug | Metformin 500mg three times daily |
|
| Pioglitazone | Drug | Pioglitazone 30mg once daily |
|
| 3 months |
| Serum Dehydroepiandrosterone sulfate (DHEAS) level | Serum concentration of Dehydroepiandrosterone sulfate | 3 months |
| Serum follicle stimulating hormone (FSH) level | Serum concentration of follicle stimulating hormone | 3 months |
| Serum luteinizing hormone (LH) level | Serum concentration of luteinizing hormone | 3 months |
| Fasting Blood Sugar (FBS) | Fasting Blood Sugar | 3 months |
| Fasting Serum Insulin level | Serum concentration of insulin | 3 months |
| Serum homocysteine level | Serum concentration of homocysteine | 3 months |
| Number of patients with adverse events | Number of patients with adverse events | 3 months |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |