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Wellbutrin XL

Phase 2

Orgasmic Disorder | Small molecule | Other |GSK plc|Last Updated: Jul 20, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00248209Female Orgasmic Disorder (FOD) and Wellbutrin XLPHASE2 COMPLETED 48May 1, 2004Apr 1, 2007Jul 20, 20111 United States
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Study Endpoints
Primary Endpoints
The primary objective of this study is to evaluate the effect of bupropion XL on the ease and frequency of achieving orgasm in sexual activity.
8 weeks of treatment
Secondary Endpoints
Secondary objectives will be to investigate the effects of bupropion XL on changes in sexual arousal and sexual pleasure.
8 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Wellbutrin XL or placeboPLACEBO_COMPARATOR1 arms - Wellbutrin XL or placebo
Interventions
NameTypeDescription
Wellbutrin XLDRUGPatients randomized to the bupropion treatment group will receive bupropion XL150 mg in the AM for 7 days increasing to 300mg/day (single daily dose). The investigator can increase the dose to 450mg per day at Day 28 if clinically indicated.
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Eligibility Criteria
Age Range20 Years — 50 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: A subject must: 1. Be able to understand and sign a written informed consent 2. Be a premenopausal female between 20 and 50 years of age, inclusive 3. Use active birth control, and be non-lactating, with a negative urine pregnancy test 4. Have no evidence of mood or anxiety dis...

Countries:United States
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