NCT00842140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

July 22, 2010

Status Verified

February 1, 2009

Enrollment Period

2.9 years

First QC Date

February 10, 2009

Last Update Submit

July 21, 2010

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndromeOral Contraceptives, HormonalCardiovascular DiseaseEndothelium

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR

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

Drug: oral contraceptive

2

EXPERIMENTAL

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

3

EXPERIMENTAL

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

Drug: Oral contraceptive plus metformin

Interventions

oral contraceptiveDRUG

oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate)once a day for 12 months

Also known as: Belara
1
Oral contraceptive plus spironolactoneDRUG

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.

Also known as: Belara, Spironolactone
2
Oral contraceptive plus metforminDRUG

Oral contraceptive (0,03mg ethynylestradiol and 2mg chlormadinone acetate) plus 850 mg of metformin

Also known as: Belara, Metformin
3

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 35 years
  • diagnosis of PCOS by Rotterdam Consensus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeCardiovascular Diseases

Interventions

Contraceptives, OralBelaraSpironolactoneMetformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesLactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Rui A Ferriani, MD, PhD

    University of Sao Paulo

    STUDY DIRECTOR

  • Marcos Felipe S de Sa, MD, PhD

    University of Sao Paulo

    STUDY CHAIR

  • Carolina S Vieira, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

February 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 22, 2010

Record last verified: 2009-02

Locations

BR(1)