Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran
NCT Number: NCT02689843
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.
Looking for future studies?
Notify Me18 year–35 year
Female
Interventional
Early Phase 1
Shiraz, Fars, Iran
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily
Other names: CC-S
Metformin 500mg three times daily
Pioglitazone 30mg once daily
Time frame: 3 months
Serum concentration of a component of complement cascade: C3
Time frame: 3 months
Serum concentration of a component of complement cascade: C4
Time frame: 3 months
Serum concentration of high-sensitive C-reactive protein (hs-CRP)
Time frame: 3 months
Serum concentration of total Testosterone
Time frame: 3 months
Serum concentration of free Testosterone
Time frame: 3 months
Serum concentration of Dehydroepiandrosterone sulfate
Time frame: 3 months
Serum concentration of follicle stimulating hormone
Time frame: 3 months
Serum concentration of luteinizing hormone
Time frame: 3 months
Fasting Blood Sugar
Time frame: 3 months
Serum concentration of insulin
Time frame: 3 months
Serum concentration of homocysteine
Time frame: 3 months
Number of patients with adverse events
Shiraz University of Medical Sciences
Other
Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)
Acronym: AntiPCO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03229408
46, XX Disorders of Sex Development, Adnexal Diseases
Chicago, Illinois, United States
View Trial DetailsNCT02302326
Adnexal Diseases, Cysts
Valencia, Spain
View Trial DetailsNCT00907153
Adnexal Diseases, Cysts
Hershey, Pennsylvania, United States
View Trial DetailsNCT06551285
Adnexal Diseases, Cysts
Valencia, Spain
View Trial Details