Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS

• Status: Completed
• Trial end date: 2018-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shiraz University of Medical Sciences
• Treatments: Cyproterone; Cyproterone Acetate; Estradiol; Ethinyl Estradiol; Metformin; Pioglitazone; Spironolactone

Criteria

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