Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication RIVELSA ® is indicated for use by females of reproductive age to prevent pregnancy. RIVELSA is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) FDA label
Also known as Quartette®
DR-103 · 1 trial · 1 indication
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(4)/(total number of 91-day cycles)
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. 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)
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. 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)
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI). 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-103 or \> 7 days after stopping the combination EE/LNG treatment of DR-103. The estimated date of conception and gestational age of the fetus was determined by transvaginal or abdominal ultrasound. In order to compare the efficacy of extended treatment with DR-103 to conventional 28-day cyclic oral contraceptive treatment, the 91-day DR-103 treatment cycle was separated into three 28-day cycle-equivalents, derived from the 84-day active combination (EE/LNG) pill period of each 91-day extended cycle. 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)
The on-treatment time frame spanned the time during which study drug was administered until 3 weeks beyond the last study drug date. Relationship to study drug was assessed by the investigator. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention.
| Arm | Type | Description |
|---|---|---|
| DR-103 | EXPERIMENTAL | Four 91-day cycles of the DR-103 regimen: * 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; * 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; * 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; * 7 days of 10 mcg EE. |
| Name | Type | Description |
|---|---|---|
| DR-103 | DRUG | One tablet daily. Four 91-day cycles of the DR-103 regimen: 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE. |
Inclusion Criteria: * Sexually active at risk for pregnancy * Agreement to use study OC 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 FDA-approved protocol Exclusion Criteria:...
DR-103 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited for pregnancy prevention. It is being studied as a contraceptive in women aged 18 years and older. DR-103 is in Phase 3 clinical development and has not been approved by the FDA.
DR-103 is being developed for pregnancy prevention, meaning it is intended as a contraceptive for women of reproductive age. Its only registered clinical study enrolled healthy female volunteers aged 18 years and older. The indication under investigation is pregnancy prevention, not treatment of an existing condition.
DR-103 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program evaluating DR-103 for pregnancy prevention. No other developer or partner is associated with the asset in its registered Phase 3 study.
DR-103 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. Because the program remains investigational, DR-103 is not FDA approved for pregnancy prevention or any other indication.
DR-103 has been evaluated in one registered Phase 3 trial, NCT00996580, titled A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy. The trial was completed, enrolled 3,597 participants, was conducted in the United States, and was uncontrolled, enrolling healthy female volunteers aged 18 years and older.