Phase 3
Completed N=1,887
Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ
Contraception · Ovulation Inhibition · Contraceptives, Oral
Source: ClinicalTrials.gov NCT00567164 ↗
Enrolled (actual)
1,887
Serious AEs
1.1%
Results posted
Mar 2014
Primary outcomePrimary: Pearl Index — 1.65; 1.92 Pregnancies per 100 years of exposure
Summary
The purpose of this study is to determine whether the study drug is safe and effective.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pearl Index |
1.65; 1.92 | — |
| SECONDARY Number of Bleeding Days (Including Spotting Days) |
39.9; 46.8; 51.8 | 0.0001 sig |
| SECONDARY Number of Bleeding Days (Excluding Spotting Days) |
19.4; 21.4; 32.9 | — |
| SECONDARY Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 1. |
16.6; 18.5; 19.7; 8.3; 9.1; 12.6 | — |
| SECONDARY Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 2. |
11.0; 12.5; 14.8; 5.1; 5.4; 9.7 | — |
| SECONDARY Number of Days With Bleeding (Including and Excluding Spotting) Within 90-day Reference Period 3 |
10.0; 11.4; 14.8; 4.7; 4.9; 9.4 | — |
| SECONDARY Number of Days With Bleeding/ (Including and Excluding Spotting) Within 90-day Reference Period 4 |
9.0; 9.5; 13.6; 4.2; 4.0; 8.4 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 1 |
84.2; 83.8; 66.8 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 2 |
85.9; 84.7; 86.7 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 3 |
78.6; 79.2; 84.6 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 4 |
73.4; 66.1; 86.3 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 5 |
78.0; 69.0; 85.8 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 6 |
77.7; 69.8; 85.2 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 7 |
78.3; 70.0; 84.0 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 8 |
82.1; 69.2; 86.7 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 9 |
73.9; 80.0; 85.5 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 10 |
78.9; 70.0; 84.6 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 11 |
55.6; 62.5; 85.9 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 12 |
0; 33.3; 78.6 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 13 |
0; 20.5 | — |
| SECONDARY Percentage of Participants With a Withdrawal Bleeding Episode for Cycle 14 |
9.1 | — |
| SECONDARY Number of Intracyclic Bleeding Days |
8.0; 14.4; 7.1; 3.6; 7.3; 5.2 | — |
| SECONDARY Number of Scheduled and Unscheduled Bleeding Days |
20.6; 21.9; 20.0; 25.3 | — |
| SECONDARY Length of Cycles |
70.9; 67.6; 28.8 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy women between 18 and 45 requesting oral contraception. Smokers may not exceed 35 years of age.
Exclusion Criteria
- The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
Data sourced from ClinicalTrials.gov (NCT00567164). 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. Informational only — not medical advice.