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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Polycystic Ovary Syndrome
Intervention	Drug: oral contraceptive Drug: Oral contraceptive plus spironolactone Drug: Oral contraceptive plus metformin
Phase	N/A
Sponsor	University of Sao Paulo
Responsible Party	University of Sao Paulo
ClinicalTrials.gov Identifier	NCT00842140
First Received	February 10, 2009
Last Updated	July 21, 2010
Last verified	February 2009

Tracking Information[ + expand ][ + ]

First Received Date	February 10, 2009
Last Updated Date	July 21, 2010
Start Date	February 2006
Estimated Primary Completion Date	January 2009
Current Primary Outcome 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] [Designated as safety issue: Yes]
Current Secondary Outcome 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] [Designated as 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] [Designated as 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] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Safety of Hormonal Contraceptives Therapies in Polycystic Ovary Syndrome (PCOS) Women
Official Title	Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women
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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome
Intervention	Drug: oral contraceptive oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months Other Names: BelaraDrug: 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. Other Names: Belara Spironolactone Drug: Oral contraceptive plus metformin Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin Other Names: Belara Metformin
Study Arm (s)	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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	75
Estimated Completion Date	January 2009
Estimated Primary Completion Date	January 2009
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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT00842140
Other Study ID Numbers	HCRP15811/2005
Has Data Monitoring Committee	No
Information Provided By	University of Sao Paulo
Study Sponsor	University of Sao Paulo
Collaborators	Not Provided
Investigators	Study Director: Rui A Ferriani, MD, PhD University of Sao PauloStudy Chair: Marcos Felipe S de Sa, MD, PhD University of Sao PauloPrincipal Investigator: Carolina S Vieira, MD, PhD University of Sao Paulo
Verification Date	February 2009

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