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DR-102

Phase 3

Contraception | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Nov 9, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment2,858
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01178125A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of PregnancyPHASE3 COMPLETED 2,858Aug 1, 2010Jan 1, 2013Nov 9, 202162 United States, Israel
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Study Endpoints
Primary Endpoints
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
thirteen 28-day cycles

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.

Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
thirteen 28-day cycles

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 Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
thirteen 28-day cycles

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.

Secondary Endpoints
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
thirteen 28-day cycles
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
thirteen 28-day cycles
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
thirteen 28-day cycles
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
DR-102EXPERIMENTALdesogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
Interventions
NameTypeDescription
DR-102DRUG -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites62

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...

Countries:United StatesIsrael
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