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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842140
• Other study ID #: HCRP15811/2005
• Status: Completed
• Phase: N/A
• First received: February 10, 2009
• Last updated: July 21, 2010
• Start date: February 2006
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• oral contraceptive
oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months
• 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.
• Oral contraceptive plus metformin
Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	Yes
Secondary	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.		12 months	Yes
Secondary	to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on hemostatic variables.		12 months	Yes
Secondary	to compare the effect of an oral contraceptive alone or associated with an anti-androgenic drug (spironolactone) or associated with metformin on metabolic variables.		12 months	Yes