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

NCT ID: NCT02689843

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-12-30

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).

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cyproterone compound + Spironolactone

Cyproterone compound (Cyproterone acetate 2mg+Ethinyl estradiol 35 mcg) once daily + Spironolactone 50 mg twice daily

Group Type: ACTIVE_COMPARATOR

Cyproterone compound + Spironolactone

Intervention Type: DRUG

Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily

Metformin

Metformin 1500 mg daily

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin 500mg three times daily

Pioglitazone

Pioglitazone 30 mg daily

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

Pioglitazone 30mg once daily

Interventions

Cyproterone compound + Spironolactone

Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily

Intervention Type: DRUG

Metformin

Metformin 500mg three times daily

Intervention Type: DRUG

Pioglitazone

Pioglitazone 30mg once daily

Intervention Type: DRUG

Other Intervention Names

CC-S

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mesbah Shams, MD

Associate professor of internal medicine and endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mesbah Shams, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Gholamhossein R Omrani, MD

Role: STUDY_CHAIR

Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Locations

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

CT-P-9145-4025

Identifier Type: -

Identifier Source: org_study_id