Efficacy and Safety Oral Contraceptive Study
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ClinicalTrials.gov Identifier: NCT00185484 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : December 31, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contraception | Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1113 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers |
Study Start Date : | March 2004 |
Actual Study Completion Date : | January 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 |
Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles |
- Rate of unintended pregnancies (Pearl index) [ Time Frame: 13 cycles of 28 days ]
- Physical and gynecological examination [ Time Frame: screening, cycle 6 and final examination ]
- Vital signs [ Time Frame: each visit ]
- Body weight [ Time Frame: each visit ]
- Cervical smear [ Time Frame: each visit ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy woman requesting contraception
- Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)
Exclusion Criteria:
- Any conditions might interfere study outcome

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185484
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00185484 |
Other Study ID Numbers: |
91353 308021 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | December 31, 2014 |
Last Verified: | December 2014 |
Oral contraception |