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Completed

NCT Number: NCT02689843

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-35 years
  • Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria 2003 (two out of three required):
  • Oligomenorrhea or anovulation
  • Clinical and/or biochemical signs of hyperandrogenism
  • 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

Treatment and study plan

Cyproterone compound + Spironolactone

Drug

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

Other names: CC-S

metformin

Drug

Metformin 500mg three times daily

pioglitazone

Drug

Pioglitazone 30mg once daily

Primary outcomes

  1. Serum C3 level

    Time frame: 3 months

    Serum concentration of a component of complement cascade: C3

  2. Serum C4 level

    Time frame: 3 months

    Serum concentration of a component of complement cascade: C4

  3. Serum high-sensitive CRP (C-reactive protein)

    Time frame: 3 months

    Serum concentration of high-sensitive C-reactive protein (hs-CRP)

Secondary outcomes

  1. Serum total Testosterone level

    Time frame: 3 months

    Serum concentration of total Testosterone

  2. Serum free Testosterone level

    Time frame: 3 months

    Serum concentration of free Testosterone

  3. Serum Dehydroepiandrosterone sulfate (DHEAS) level

    Time frame: 3 months

    Serum concentration of Dehydroepiandrosterone sulfate

  4. Serum follicle stimulating hormone (FSH) level

    Time frame: 3 months

    Serum concentration of follicle stimulating hormone

  5. Serum luteinizing hormone (LH) level

    Time frame: 3 months

    Serum concentration of luteinizing hormone

  6. Fasting Blood Sugar (FBS)

    Time frame: 3 months

    Fasting Blood Sugar

  7. Fasting Serum Insulin level

    Time frame: 3 months

    Serum concentration of insulin

  8. Serum homocysteine level

    Time frame: 3 months

    Serum concentration of homocysteine

  9. Number of patients with adverse events

    Time frame: 3 months

    Number of patients with adverse events

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: AntiPCO

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2016
Registry last updated
Nov 12, 2019

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.

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