Efficacy and Safety of Two Extended Regimens (Yaz Flex) in Comparison With the Conventional Regimen of YAZ - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00567164

Purpose

The purpose of this study is to determine whether the study drug is safe and effective

Condition	Intervention	Phase
Contraception Ovulation Inhibition Contraceptives, Oral	Drug: Yaz (SH T00186D) Drug: SH T00186D Drug: SH T00189D, SH T470PD + Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Multicenter, Open-label, Three-arm, Active-controlled Study to Assess the Efficacy and Safety of the Oral Contraceptive SH T00186D in Two Flexible Extended Regimens and a Conventional Regimen of Yaz in 1756 Healthy Females for 1 Year

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Estradiol Ethinyl estradiol

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Number of observed unintended pregnancies (evaluated using the Pearl Index) [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of bleeding and spotting days [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]
Number of intracyclic bleeding days, including and excluding spotting [ Time Frame: Approximately 1 year ] [ Designated as safety issue: No ]

Enrollment:	1885
Study Start Date:	October 2007
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Arm 1	Drug: Yaz (SH T00186D) 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Experimental: Arm 2	Drug: SH T00186D 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Experimental: Arm 3	Drug: SH T00189D, SH T470PD + Placebo 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone + placebo tablet

Detailed Description:

The primary efficacy parameter is the number of observed unintended pregnancy during 1 year of treatment. Secondary efficacy parameter include bleeding parameters and menstrual related symptoms Safety parameters included assessment of adverse events, laboratory evaluations.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.

Exclusion Criteria:

The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567164

Show 83 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00567164 History of Changes
Other Study ID Numbers:	91698, 311642
Study First Received:	December 3, 2007
Last Updated:	December 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Oral Contraception
Birth Control pill
Healthy women requesting oral contraception
Contraceptive efficacy

Additional relevant MeSH terms:

Contraceptive Agents
Contraceptives, Oral
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on February 12, 2012