Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DR-1021 · 2 trials · 2 indications
Levels of estradiol were measured throughout the study from blood samples.
Levels of follicle stimulating hormone were measured throughout the study from blood samples.
Levels of inhibin-B were measured throughout the study from blood samples.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| DR-1021 | EXPERIMENTAL | After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Mircette | ACTIVE_COMPARATOR | After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3). |
| Name | Type | Description |
|---|---|---|
| DR-1021 | DRUG | 1 tablet daily |
| Mircette® | DRUG | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. |
| Kariva® | DRUG | Twenty-one 150 μg desogestrel/20 μg ethinyl estradiol (EE) combination tablets plus two placebo tablets plus five 10 μg EE tablets. |
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-1021 is an investigational small molecule being developed for contraception and for use in healthy volunteers. It is being studied as a low-dose 28-day oral contraceptive in women aged 18 years and older. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.
DR-1021 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. Teva is conducting clinical trials to evaluate the safety and efficacy of DR-1021 as an oral contraceptive and in healthy female volunteers.
DR-1021 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials have been completed, including one large study with 1,347 participants evaluating the drug as a low-dose 28-day oral contraceptive.
DR-1021 has completed two Phase 3 clinical trials. NCT00362479 was an open-label study evaluating the safety and efficacy of a low-dose 28-day oral contraceptive in 1,347 women in the United States. NCT00544882 was a study in 61 healthy women to evaluate hormone patterns and ovarian follicular activity with DR-1021.
DR-1021 is a small molecule being developed as an oral contraceptive. It is designed to be taken daily in a 28-day regimen to prevent pregnancy. The exact molecular target of DR-1021 has not been disclosed in available information, so its specific mechanism of action is not fully characterized in public data.