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NCT00248209 · ClinicalTrials.gov registry record · Phase 2
Female Orgasmic Disorder (FOD) and Wellbutrin XL
A Phase 2 study of Orgasmic Disorder, sponsored by Segraves, R., T., M.D., Ph.D..
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT00248209 is a Phase 2 study of Orgasmic Disorder that has completed, run by Segraves, R., T., M.D., Ph.D.. The registered enrollment target is 48 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00248209, a Phase 2 study of Orgasmic Disorder, has completed, sponsored by Segraves, R., T., M.D., Ph.D..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will improve orgasmic function in pre-menopausal women with a primary complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder. This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug, and sexual histories will be obtained. Patients who continue to meet screening inclusion/exclusion criteria at their baseline visit will be randomly assigned to either placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire and activity will be assessed by patient diaries, investigator interview of sexual functioning every two weeks, and by standardized questionnaire every four weeks. The primary endpoint will be the increase in orgasm completion as measured by the Changes in Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.
Conditions Studied
Interventions
- DRUG Wellbutrin XL
Study Locations (1)
Ohio
- MetroHealth Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2004-05 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00248209
The ClinicalTrials.gov registry entry for NCT00248209 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Segraves, R., T., M.D., Ph.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Orgasmic Disorder appearing as the primary indexed condition, and to 1 intervention - of which Wellbutrin XL is the first listed.
NCT00248209 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00248209 about?
NCT00248209 is a clinical study titled "Female Orgasmic Disorder (FOD) and Wellbutrin XL". A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will imp...
What is the current status of trial NCT00248209?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2004-05. Estimated completion is 2007-04.
What conditions does trial NCT00248209 study?
This clinical trial studies the following conditions: Orgasmic Disorder.
What interventions are being tested in trial NCT00248209?
The interventions under investigation include: Wellbutrin XL (DRUG).
Who is sponsoring clinical trial NCT00248209?
This trial is sponsored by Segraves, R., T., M.D., Ph.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00248209 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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