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

Shiraz University of Medical Sciences

Status and phase: Completed; Early Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Drug: Pioglitazone; Drug: Cyproterone compound + Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT02689843

CT-P-9145-4025

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Cyproterone compound + Spironolactone

Active Comparator group

Description:

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

Treatment:

Drug: Cyproterone compound + Spironolactone

Metformin

Active Comparator group

Description:

Metformin 1500 mg daily

Treatment:

Drug: Metformin

Pioglitazone

Active Comparator group

Description:

Pioglitazone 30 mg daily

Treatment:

Drug: Pioglitazone