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

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ClinicalTrials.gov Identifier: NCT00842140
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: oral contraceptive Drug: Oral contraceptive plus spironolactone Drug: Oral contraceptive plus metformin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women
Study Start Date : February 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
This group will receive an oral contraceptive containing 0,03mg ethynylestradiol and 2mg chlormadinone acetate
Drug: oral contraceptive
oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months
Other Name: Belara
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.
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.
Other Names:
  • Belara
  • Spironolactone
Experimental: 3
The patient will receive an oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg metformin.
Drug: Oral contraceptive plus metformin
Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin
Other Names:
  • Belara
  • Metformin



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842140


Locations
Brazil
University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Rui A Ferriani, MD, PhD University of Sao Paulo
Study Chair: Marcos Felipe S de Sa, MD, PhD University of Sao Paulo
Principal Investigator: Carolina S Vieira, MD, PhD University of Sao Paulo

Responsible Party: Rui Alberto Ferriani, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00842140     History of Changes
Other Study ID Numbers: HCRP15811/2005
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: February 2009

Keywords provided by University of Sao Paulo:
Polycystic ovary syndrome
Oral Contraceptives, Hormonal
Cardiovascular Disease
Endothelium

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Contraceptive Agents
Chlormadinone Acetate
Contraceptives, Oral
Spironolactone
Ethinyl Estradiol
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Androgen Antagonists
Contraceptives, Oral, Synthetic