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

University of Sao Paulo

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Oral contraceptive plus spironolactone; Drug: Oral contraceptive plus metformin; Drug: oral contraceptive

Study type: Interventional

Funder types: Other

Identifiers

NCT00842140

HCRP15811/2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: oral contraceptive

2

Experimental group

Description:

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.

Treatment:

Drug: Oral contraceptive plus spironolactone

3

Experimental group

Description:

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

Treatment:

Drug: Oral contraceptive plus metformin