Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women

Official Title: “Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women”

The purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with Spironolactone.

Polycystic ovary syndrome (PCOS) is associated with comorbidities that may contribute to increased risk of cardiovascular disease (CVD). Oral contraceptives (OC) have been the mainstay of PCOS pharmacological therapy for decades. However, in non-hyperandrogenic women, OC use is associated with higher risk of cardiovascular disease, raising concern about a possible worsening of the unfavorable metabolic and cardiovascular profile of PCOS patients.

There is lack of evidence about the impact of PCOS pharmacological therapies on cardiovascular risk markers and the long-term safety of these drugs in PCOS has not been established. The aim of this study is to compare the effect of an OC alone or associated with an anti-androgenic drug (spironolactone) on echografic cardiovascular risk markers, metabolic and hemostatic variables.

Intervention(s) in this Clinical Trial

• Drug: oral contraceptive
  • oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months
• Drug: Oral contraceptive plus spironolactone
  • The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.
• Drug: Oral contraceptive plus metformin
  • Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate
• Experimental: 2
  • The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 100 mg spironolactone. One pill each once a day for twelve months.
• Experimental: 3
  • The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg metformin.

Primary Measures

• To compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on echografic cardiovascular risk markers.
  • Time Frame: 12 months
    Safety Issue?: Yes

Secondary Measures

• to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on seric cardiovascular risk markers.
  • Time Frame: 12 months
    Safety Issue?: Yes
• to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on hemostatic variables.
  • Time Frame: 12 months
    Safety Issue?: Yes
• to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on metabolic variables.
  • Time Frame: 12 months
    Safety Issue?: Yes

Inclusion Criteria:

• age between 18 and 35 years
• diagnosis of PCOS by Rotterdam Consensus

Exclusion Criteria:

• smoking, alcoholism, drug addiction;
• current pregnancy;
• current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives;
• current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device);
• antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins;
• presence of systemic diseases (DM2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia);
• personal history of arterial or venous thrombosis; chronic or acute inflammatory processes;
• puerperium of 12 weeks or less

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Sao Paulo Other

Overall Clinical Trial Officials and Contacts

Rui A Ferriani, MD, PhD Study Director University of Sao Paulo  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00842140

Study ID Number: HCRP15811/2005

ClinicalTrials.gov Identifier: NCT00842140

Health Authority: Brazil: Ministry of Health