NCT00988910

Brief Summary

The purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

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

January 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

October 1, 2009

Last Update Submit

June 25, 2014

Conditions

Contraception

Keywords

Combined Oral ContraceptivesCOC

Outcome Measures

Primary Outcomes (2)

  • Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)

    at 12 months

  • Sexual well-being evaluated by the Female Sexual Function Index (FSFI)

    at 12 months

Study Arms (2)

Group 1

Drug: EE30-DRSP (Yasmin, BAY86-5131)

Group 2

Drug: Other combined oral contraceptives

Interventions

EE30-DRSP (Yasmin, BAY86-5131)DRUG

DRSP-containing combined oral contraceptives according to the normal routine praxis

Group 1
Other combined oral contraceptivesDRUG

Other combined oral contraceptives according to the normal routine praxis

Group 2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women using Combined Oral Contraceptive (COC)

You may qualify if:

  • According to the label of the prescribed Combined Oral Contraceptive (COC)
  • first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
  • intention to use current COC for 1 year at least

You may not qualify if:

  • Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Italy

Location

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

IT(1)