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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00567164 |
The purpose of this study is to determine whether the study drug is safe and effective
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Yaz (SH T00186D) Drug: SH T00186D Drug: SH T00189D, SH T470PD |
Phase III |
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 |
Estimated Enrollment: | 1756 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 2: Active Comparator |
Drug: SH T00186D
0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
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Arm 3: Active Comparator |
Drug: SH T00189D, SH T470PD
0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone + placebo tablet
|
Arm 1: Active Comparator |
Drug: Yaz (SH T00186D)
0.02 mg ethinyl estradiol as betadex clathrate and 3.0 mg drospirenone
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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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 91698, 311642 |
Study First Received: | December 3, 2007 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00567164 |
Health Authority: | United States: Food and Drug Administration |
Oral Contraception Birth Control pill Healthy women requesting oral contraception Contraceptive efficacy |
Estradiol 3-benzoate Estradiol valerate Drospirenone Ethinyl Estradiol |
Estradiol 17 beta-cypionate Healthy Polyestradiol phosphate Estradiol |