Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DR-1011 · 1 trial · 1 indication
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
DR-1011 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited as a low dose combination oral contraceptive. It is being studied in a Phase 3 trial for contraception in the endocrine therapeutic area. It is not a marketed product.
DR-1011 is being developed for contraception. It is an extended-cycle, low dose combination oral contraceptive studied in adult women aged 18 years and older. The Phase 3 trial enrolled 2,235 participants in the United States.
DR-1011 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the Phase 3 study evaluating the drug as an extended-cycle, low dose combination oral contraceptive.
DR-1011 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was an open-label, uncontrolled trial that enrolled 2,235 participants.
DR-1011 has been studied in one Phase 3 trial, NCT00196326, titled an open-label study to evaluate the efficacy and safety of an extended-cycle, low dose combination oral contraceptive. The trial is completed, enrolled 2,235 female healthy volunteers aged 18 years and older, and was conducted in the United States.