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norelgestromin + ethinyl estradiol; mercilon

Phase 3

Contraception | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 8, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment4,762
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00236769A Study of Efficacy and Safety With the Transdermal Contraceptive System.PHASE3 COMPLETED 1,751 — — Nov 1, 1997Oct 1, 1999Nov 17, 2010 - —
NCT00236782A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.PHASE3 COMPLETED 1,517 — — Oct 1, 1997Mar 1, 1999Jun 8, 2011 - —
NCT00236795A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.PHASE3 COMPLETED 1,494 — — Jan 1, 1997Mar 1, 1999Jun 8, 2011 - —
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Study Endpoints
Primary Endpoints
Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.
Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.
Secondary Endpoints
Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.
Cycle control and compliance were assessed with diary cards containing bleeding and dosing information.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
norelgestromin + ethinyl estradiolDRUG -
norelgestromin + ethinyl estradiol; mercilonDRUG -
norelgestromin + ethinyl estradiol; triphasil.DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy women with regular menstrual cycles * sexually active and at risk of pregnancy * nonpregnant * acceptable body mass index (BMI) * last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since * sitting BP\<140mmHg/\<90mmHg * 1 normal men...

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