Polycystic Ovary Syndrome
Conditions
Keywords
Inflammation, Complement system proteins, Homocysteine, C-Reactive Protein, Cyproterone, Ethinyl Estradiol, Androgen Antagonists, Metformin, Thiazolidinediones, Pioglitazone
Brief summary
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.
Detailed description
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).
Interventions
DRUGCyproterone compound + Spironolactone
Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily
DRUGMetformin
Metformin 500mg three times daily
DRUGPioglitazone
Pioglitazone 30mg once daily
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-35 years * Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required): 1. Oligomenorrhea or anovulation 2. Clinical and/or biochemical signs of hyperandrogenism 3. Polycystic ovaries (by ultrasound)
Exclusion criteria
* Smoking * Pregnancy * Diabetes mellitus * Renal failure (serum creatinine \>1.5) * Congenital adrenal hyperplasia * Hyper or hypothyroidism * Sex hormone therapy or antiandrogen therapy during the last three months * Unexplained serum alanin aminotransferase (ALT) elevation more than 2.5 times above normal range * Any systemic or febrile illnesses * Use of glucocorticoid or anti-inflammatory drugs during the last three months * Androgen secreting tumor * Malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum C3 level | 3 months | Serum concentration of a component of complement cascade: C3 |
| Serum C4 level | 3 months | Serum concentration of a component of complement cascade: C4 |
| Serum high-sensitive CRP (C-reactive protein) | 3 months | Serum concentration of high-sensitive C-reactive protein (hs-CRP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum follicle stimulating hormone (FSH) level | 3 months | Serum concentration of follicle stimulating hormone |
| Serum luteinizing hormone (LH) level | 3 months | Serum concentration of luteinizing hormone |
| Fasting Blood Sugar (FBS) | 3 months | Fasting Blood Sugar |
| Serum total Testosterone level | 3 months | Serum concentration of total Testosterone |
| Serum homocysteine level | 3 months | Serum concentration of homocysteine |
| Number of patients with adverse events | 3 months | Number of patients with adverse events |
| Fasting Serum Insulin level | 3 months | Serum concentration of insulin |
| Serum free Testosterone level | 3 months | Serum concentration of free Testosterone |
| Serum Dehydroepiandrosterone sulfate (DHEAS) level | 3 months | Serum concentration of Dehydroepiandrosterone sulfate |
Countries
Iran
Outcome results
None listed