NCT00185419

Brief Summary

The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
842

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2003

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

January 13, 2009

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.

    13 treatment cycles (1 cycle= 28 days)

Secondary Outcomes (5)

  • Weight changes

    13 treatment cycles

  • Contraceptive reliability

    13 treatment cycles

  • Effects on skin condition

    13 treatment cycles

  • Changes in MDQ subscale scores

    13 treatment cycles

  • Adverse Events

    the whole study period

Study Arms (2)

Arm 1

ACTIVE COMPARATOR
Drug: Yasmin

Arm 2

ACTIVE COMPARATOR
Drug: Marvelon

Interventions

YasminDRUG

30 µg ethinylestradiol, 3mg drospirenone

Arm 1
MarvelonDRUG

30 µg ethinylestradiol, 150 µg desogestrel

Arm 2

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese female requesting contraceptives

You may not qualify if:

  • Vascular, metabolic, hepatic, renal, oncologic and other diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ask Contact, China

Location

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combinationDesogestrel

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

CN(1)