Trial Condition(s):
Contraception
Efficacy and safety oral contraceptive study
Bayer Identifier:
91353
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age
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
Trial Summary
Enrollment Goal
1113
Trial Dates
Phase
3
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
Yes
Where to Participate
Locations
| Locations |
|---|
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Rate of unintended pregnancies (Pearl index)Timeframe: 13 cycles of 28 days
Secondary Outcome
- Physical and gynecological examinationTimeframe: screening, cycle 6 and final examination
- Vital signsTimeframe: each visit
- Body weightTimeframe: each visit
- Cervical smearTimeframe: each visit
Additional Information
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