Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT02689843
- Lead Sponsor
- Shiraz University of Medical Sciences
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
-
Age 18-35 years
-
Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
- Oligomenorrhea or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries (by ultrasound)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyproterone compound + Spironolactone Cyproterone compound + Spironolactone Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily Metformin Metformin Metformin 1500 mg daily Pioglitazone Pioglitazone Pioglitazone 30 mg daily
- Primary Outcome Measures
Name Time Method Serum C3 level 3 months Serum concentration of a component of complement cascade: C3
Serum high-sensitive CRP (C-reactive protein) 3 months Serum concentration of high-sensitive C-reactive protein (hs-CRP)
Serum C4 level 3 months Serum concentration of a component of complement cascade: C4
- Secondary Outcome Measures
Name Time Method Serum free Testosterone level 3 months Serum concentration of free Testosterone
Serum Dehydroepiandrosterone sulfate (DHEAS) level 3 months Serum concentration of Dehydroepiandrosterone sulfate
Serum homocysteine level 3 months Serum concentration of homocysteine
Serum total Testosterone level 3 months Serum concentration of total Testosterone
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
Fasting Serum Insulin level 3 months Serum concentration of insulin
Number of patients with adverse events 3 months Number of patients with adverse events
Trial Locations
- Locations (1)
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
🇮🇷Shiraz, Fars, Iran, Islamic Republic of