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Wellbutrin XL

Phase 2

Orgasmic Disorder | Small molecule | Other |GSK plc|Last Updated: Jul 20, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Wellbutrin XL · 1 trial · 1 indication

Phase 2 1
NCT00248209Female Orgasmic Disorder (FOD) and Wellbutrin XLOrgasmic Disorder
COMPLETED48 Analytics
PHASE2COMPLETED
Female Orgasmic Disorder (FOD) and Wellbutrin XL
Orgasmic DisorderUnlock trial analytics

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 to 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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Frequently asked questions about Wellbutrin XL

What is Wellbutrin XL used for?

Wellbutrin XL is a small molecule drug being studied for Orgasmic Disorder and Depressive Disorder. It is developed by GSK plc. The drug is currently in Phase 2 clinical development for these conditions.

Who makes Wellbutrin XL?

Wellbutrin XL is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is being investigated for use in Orgasmic Disorder and Depressive Disorder.

What phase is Wellbutrin XL in?

Wellbutrin XL is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy for the studied indications.

What clinical trials is Wellbutrin XL in?

Wellbutrin XL has been studied in clinical trials including NCT00248209, a Phase 2 trial for Female Orgasmic Disorder, and NCT00439868, a Phase 1 trial for Depressive Disorder. Both trials were completed in the United States.

Is Wellbutrin XL the same as bupropion?

Wellbutrin XL is a brand name for the drug bupropion, which is used to treat depression. However, the specific formulation and delivery mechanism of Wellbutrin XL may differ from other bupropion products.