Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00266032

Purpose

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

Condition	Intervention	Phase
Contraception	Drug: YAZ (SH T00186 DF) Drug: YAZ extended (SH T 04210 A)	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open, Randomized, Parallel-Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T 00186 D in Extended Cycles vs. a Standard Regimen in Healthy Female Volunteers for up to Two Years

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of days with bleeding/spotting [ Time Frame: Approximately 1 year, followed by a 1-year safety extension ] [ Designated as safety issue: No ]
Number of unintended pregnancies (Pearl Index, life table analysis) [ Time Frame: Approximately 1 year, followed by a 1-year safety extension ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Parameters of safety and tolerability [ Time Frame: Approximately 1 year, followed by a 1-year safety extension ] [ Designated as safety issue: Yes ]

Enrollment:	1310
Study Start Date:	December 2005
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: YAZ extended (SH T 04210 A) Ethinylestradiol (EE) and drospirenone (DRSP), daily intake of 1 tablet for an intended period of 120 days, followed by a 4-day tablet-free interval.Minimal period of tablet intake between two tablet-free intervals is 24 days. After each 4-day tablet-free interval a new intended 120-day period will start again
Arm 2: Experimental	Drug: YAZ extended (SH T 04210 A) EE and DRSP, 120-day period with consecutive daily intake of 1 tablet followed by a 4-day tablet-free interval over a total of 3 periods
Arm 3: Placebo Comparator	Drug: YAZ (SH T00186 DF) EE and DRSP, 24-day period with daily intake of 1 active tablet, followed by a 4-day period with daily intake of 1 inactive tablet (placebo)

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

- Contraindication against use of hormonal contraceptives

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266032

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91450, EudraCT 2005-002125-32, 308683
Study First Received:	December 14, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00266032 History of Changes
Health Authority:	Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010