An Early Phase 1 interventional study of Cyproterone compound + Spironolactone and Metformin in Polycystic Ovary Syndrome, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Shiraz University of Medical Sciences · Early Phase 1, Interventional, and Treatment
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).
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
Exclusion Criteria:
Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily
Drug: Cyproterone compound + Spironolactone
Metformin 1500 mg daily
Drug: Metformin
Pioglitazone 30 mg daily
Drug: Pioglitazone
Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily
Also known as: CC-S
Metformin 500mg three times daily
Pioglitazone 30mg once daily
Serum C3 level
Serum concentration of a component of complement cascade: C3
Time frame: 3 months
Serum C4 level
Serum concentration of a component of complement cascade: C4
Time frame: 3 months
Serum high-sensitive CRP (C-reactive protein)
Serum concentration of high-sensitive C-reactive protein (hs-CRP)
Time frame: 3 months
Serum total Testosterone level
Serum concentration of total Testosterone
Time frame: 3 months
Serum free Testosterone level
Serum concentration of free Testosterone
Time frame: 3 months
Serum Dehydroepiandrosterone sulfate (DHEAS) level
Serum concentration of Dehydroepiandrosterone sulfate
Time frame: 3 months
Serum follicle stimulating hormone (FSH) level
Serum concentration of follicle stimulating hormone
Time frame: 3 months
Serum luteinizing hormone (LH) level
Serum concentration of luteinizing hormone
Time frame: 3 months
Fasting Blood Sugar (FBS)
Fasting Blood Sugar
Time frame: 3 months
Fasting Serum Insulin level
Serum concentration of insulin
Time frame: 3 months
Serum homocysteine level
Serum concentration of homocysteine
Time frame: 3 months
Number of patients with adverse events
Number of patients with adverse events
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences