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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00842140
First received: February 10, 2009
Last updated: July 21, 2010
Last verified: February 2009
  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 Intervention
Polycystic Ovary Syndrome
Drug: oral contraceptive
Drug: Oral contraceptive plus spironolactone
Drug: Oral contraceptive plus metformin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Metabolic Effects of Multiple Therapies in Polycystic Ovary Syndrome (PCOS) Women

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

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 ]

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 ]

Enrollment: 75
Study Start Date: February 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Rui Alberto Ferriani, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00842140     History of Changes
Other Study ID Numbers: HCRP15811/2005
Study First Received: February 10, 2009
Last Updated: July 21, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Chlormadinone Acetate
Contraceptive Agents
Contraceptives, Oral
Spironolactone
Ethinyl Estradiol
Contraceptives, Oral, Hormonal
Metformin
Contraceptives, Oral, Synthetic
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Estrogens
Hormones
Hypoglycemic Agents
Aldosterone Antagonists
Diuretics

ClinicalTrials.gov processed this record on April 17, 2014