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| Sponsored by: |
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 |
|
Healthy |
Drug: SH T00186D Drug: SH T00189D, SH T470PD |
Phase III |
| MedlinePlus related topics: | Birth Control |
| 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: | 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
|
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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
|
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| 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 |
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Show 87 Study Locations |
| Bayer |
| Study Director: | Bayer Study Director | Bayer |
More Information
| 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 |
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