Phase 3
N=1,166
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00266032 ↗Enrolled (actual)
1,166
Serious AEs
2.7%
Results posted
Mar 2010
Primary outcome: Primary: Number of Days With Bleeding Including Spotting — 41; 61; 66 days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) (Drug); Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) (Drug); Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bayer
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days With Bleeding Including Spotting |
41; 61; 66 | <0.0001 sig |
| PRIMARY Number of Unintended Pregnancies in Yaz Flexible Arm |
8 | — |
| PRIMARY Pearl Index |
0.64 | — |
| PRIMARY Number of Unintended Pregnancies Due to Method Failure |
7 | — |
| PRIMARY Adjusted Pearl Index |
0.60 | — |
| SECONDARY Number of Days With Bleeding Excluding Spotting |
21; 24; 43 | — |
| SECONDARY Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days |
44; 66; 71 | — |
| SECONDARY Number of Bleeding / Spotting Days by 90-day Reference Period |
7.2; 9.0; 14.6; 5.3; 6.3; 10.2 | — |
| SECONDARY Number of Bleeding / Spotting Episodes in 90 Day Reference Period |
1.7; 2.0; 3.4; 1.9; 2.1; 3.4 | — |
| SECONDARY Days With Scheduled Versus Unscheduled Bleeding |
23.3; 14.0; 17.1; 46.6 | — |
Summary
The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
Eligibility Criteria
Inclusion Criteria
- Healthy women who desire contraception
- smokers ≤ 30 Years old
Exclusion Criteria
- Contraindication against use of hormonal contraceptives
Data sourced from ClinicalTrials.gov (NCT00266032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.