NCT00185354

Brief Summary

The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
422

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2004

Geographic Reach
4 countries

28 active sites

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, 2004

Completed
11 months 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

September 13, 2005

Last Update Submit

December 30, 2015

Conditions

Contraception

Keywords

FC patchcomparator study

Outcome Measures

Primary Outcomes (2)

  • Bleeding pattern and cycle control

    13 cycles

  • Number of pregnancies

    13 cycles

Secondary Outcomes (3)

  • Adverse events collection

    13 cycles

  • Endometrial biopsy

    13 cycles

  • Physical and gynecological exam

    13 cycles

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: BAY86-5016, SH P00331F

Arm 2

ACTIVE COMPARATOR
Drug: SH P00331N

Interventions

BAY86-5016, SH P00331FDRUG

Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)

Arm 1
SH P00331NDRUG

Drug amount per patch: 0.6 mg EE2 + 6 mg NGM

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Healthy female volunteer aged 18-35, smokers 18-30

You may not qualify if:

  • Contraindications for using hormonal contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Unknown Facility

Wörgl, Tyrol, 6300, Austria

Location

Unknown Facility

Bregenz, 6900, Austria

Location

Unknown Facility

Graz, 8010, Austria

Location

Unknown Facility

Vienna, 1030, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Zeltweg, 8740, Austria

Location

Unknown Facility

Helsinki, 00100, Finland

Location

Unknown Facility

Helsinki, 00180, Finland

Location

Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Turku, 20541, Finland

Location

Unknown Facility

Paris, Paris, 75018, France

Location

Unknown Facility

Biarritz, 64200, France

Location

Unknown Facility

Bordeaux, 33000, France

Location

Unknown Facility

Compiègne, 60200, France

Location

Unknown Facility

Compiègne, 60204, France

Location

Unknown Facility

Maisons Lafitte, 78600, France

Location

Unknown Facility

Montargis, 45200, France

Location

Unknown Facility

Nancy, 54042, France

Location

Unknown Facility

Pantin, 93500, France

Location

Unknown Facility

Roanne, 42300, France

Location

Unknown Facility

Saint-Germain-en-Laye, 78100, France

Location

Unknown Facility

Toulouse, 31500, France

Location

Unknown Facility

San Fernando, Cádiz, 11100, Spain

Location

Unknown Facility

Pontevedra, Galicia, 36002, Spain

Location

Unknown Facility

Salt, Girona, 17190, Spain

Location

Unknown Facility

Guadalajara, Guadalajara, 19002, Spain

Location

Unknown Facility

Barcelona, 08006, Spain

Location

Unknown Facility

Santiago de Compostela, 15701, Spain

Location

Related Links

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

FR(12)AU(6)FI(4)ES(6)