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

NCT ID: NCT00842140

Last Updated: 2010-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate

Group Type: ACTIVE_COMPARATOR

oral contraceptive

Intervention Type: DRUG

oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months

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.

Group Type: EXPERIMENTAL

Oral contraceptive plus spironolactone

Intervention Type: DRUG

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.

3

The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg metformin.

Group Type: EXPERIMENTAL

Oral contraceptive plus metformin

Intervention Type: DRUG

Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Interventions

oral contraceptive

oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months

Intervention Type: 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.

Intervention Type: DRUG

Oral contraceptive plus metformin

Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Intervention Type: DRUG

Other Intervention Names

Belara; Belara; Spironolactone; Belara; Metformin

Eligibility Criteria

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

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

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

University of Sao Paulo

Principal Investigators

Rui A Ferriani, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Marcos Felipe S de Sa, MD, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Carolina S Vieira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

HCRP15811/2005

Identifier Type: -

Identifier Source: org_study_id