Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00196326 | Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive | PHASE3 | COMPLETED | 2,235 | — | — | Jun 1, 2005 | Jun 1, 2007 | Nov 16, 2016 | 55 | United States |
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
| Arm | Type | Description |
|---|---|---|
| DR-1011 | EXPERIMENTAL | Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles. |
| Name | Type | Description |
|---|---|---|
| DR-1011 | DRUG | Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles). |
Inclusion Criteria: * Premenopausal * Not pregnant or breastfeeding * Sexually active at risk of pregnancy Exclusion Criteria: * Any contraindication to the use of oral contraceptives * Pregnancy within the last 3 months * Smoking \> 10 cigarettes per day