Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DR-102 · 1 trial · 2 indications
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
| Arm | Type | Description |
|---|---|---|
| DR-102 | EXPERIMENTAL | desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days |
| Name | Type | Description |
|---|---|---|
| DR-102 | DRUG | - |
Inclusion Criteria: * Sexually active at risk for pregnancy * Agreement to use study oral contraceptive therapy as their only method of birth control during the study * History of regular spontaneous menstrual cycles or withdrawal bleeding episodes * Others as dictated by protocol Exclusion Criter...
DR-102 is an investigational small molecule being developed for contraception, specifically female contraception. It is intended for the prevention of pregnancy. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
DR-102 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. Teva is conducting clinical trials to evaluate the efficacy and safety of DR-102 for the prevention of pregnancy.
DR-102 is in Phase 3 clinical development for contraception. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its efficacy and safety for the prevention of pregnancy.
DR-102 has one completed Phase 3 clinical trial, identified as NCT01178125, titled 'A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy.' The trial enrolled 2,858 female participants aged 18 years and older in the United States and Israel.
DR-102 is a small molecule developed for contraception. Its specific molecular target has not been disclosed in available information. The drug is being studied for its efficacy and safety in preventing pregnancy in women.