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

Polycystic Ovary Syndrome Clinical Trial

— AntiPCO  

Official title:

Effects of Treatment With Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Serum Inflammatory Markers in Patients With Polycystic Ovary Syndrome (PCOS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689843
• Other study ID #: CT-P-9145-4025
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2019
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Cyproterone compound + Spironolactone
Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily
• Metformin
Metformin 500mg three times daily
• Pioglitazone
Pioglitazone 30mg once daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum C3 level	Serum concentration of a component of complement cascade: C3	3 months
Primary	Serum C4 level	Serum concentration of a component of complement cascade: C4	3 months
Primary	Serum high-sensitive CRP (C-reactive protein)	Serum concentration of high-sensitive C-reactive protein (hs-CRP)	3 months
Secondary	Serum total Testosterone level	Serum concentration of total Testosterone	3 months
Secondary	Serum free Testosterone level	Serum concentration of free Testosterone	3 months
Secondary	Serum Dehydroepiandrosterone sulfate (DHEAS) level	Serum concentration of Dehydroepiandrosterone sulfate	3 months
Secondary	Serum follicle stimulating hormone (FSH) level	Serum concentration of follicle stimulating hormone	3 months
Secondary	Serum luteinizing hormone (LH) level	Serum concentration of luteinizing hormone	3 months
Secondary	Fasting Blood Sugar (FBS)	Fasting Blood Sugar	3 months
Secondary	Fasting Serum Insulin level	Serum concentration of insulin	3 months
Secondary	Serum homocysteine level	Serum concentration of homocysteine	3 months
Secondary	Number of patients with adverse events	Number of patients with adverse events	3 months