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

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: SH T00186D Drug: SH T00189D, SH T470PD	Phase III

MedlinePlus related topics:

Birth Control

Drug Information available for:

Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Ethinyl estradiol 1,2-Dihydrospirorenone Betadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

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

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy variable is the number of observed unintended pregnancies during 1 year of treatment. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary efficacy parameters include bleeding parameters and menstrual related symptoms. [ Time Frame: Approximately 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1756
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Active Comparator n/a	Drug: SH T00186D 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
Arm 3: Active Comparator n/a	Drug: SH T00189D, SH T470PD 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone + placebo tablet
Arm 1: Active Comparator n/a	Drug: SH T00186D 0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone

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

Contacts


Contact: Bayer Clinical Trial Contact		clinical-trials-contact@bayerhealthcare.com

Contact: For trial location information (Phone Menu Options "3" or "4")	(ex US: +1) 1-888-842-2937

Show 87 Study Locations

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91698, 311642
First Received:	December 3, 2007
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00567164
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Oral Contraception

Birth Control pill

Healthy women requesting oral contraception

Contraceptive efficacy

Study placed in the following topic categories:

Estradiol 3-benzoate

Estradiol valerate

Drospirenone

Ethinyl Estradiol

Estradiol 17 beta-cypionate

Healthy

Polyestradiol phosphate

Estradiol

ClinicalTrials.gov processed this record on November 19, 2008

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