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| 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 |
|---|---|---|
|
Oral Contraception 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: | November 2009 |
| Primary Completion Date: | August 2008 (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
|
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 88 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 91698, 311642 |
| Study First Received: | December 3, 2007 |
| Last Updated: | October 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00567164 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Oral Contraception Birth Control pill Healthy women requesting oral contraception Contraceptive efficacy |