Female Orgasmic Disorder (FOD) and Wellbutrin XL
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ClinicalTrials.gov Identifier: NCT00248209 |
Recruitment Status
:
Completed
First Posted
: November 3, 2005
Last Update Posted
: July 20, 2011
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Tracking Information | ||||
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First Submitted Date ICMJE | November 1, 2005 | |||
First Posted Date ICMJE | November 3, 2005 | |||
Last Update Posted Date | July 20, 2011 | |||
Study Start Date ICMJE | May 2004 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 8 weeks of treatment ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00248209 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Secondary objectives will be to investigate the effects of bupropion XL on changes in sexual arousal and sexual pleasure. [ Time Frame: 8 weeks of treatment ] | |||
Original Secondary Outcome Measures ICMJE |
Secondary objectives will be to investigate the effects of bupropion XLon changes in sexual arousal and sexual pleasure. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Female Orgasmic Disorder (FOD) and Wellbutrin XL | |||
Official Title ICMJE | A Multi-center, Double-blind, Placebo-controlled Study of Bupropion XL in Females With Orgasmic Disorder | |||
Brief 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. | |||
Detailed Description | Background: Female orgasmic disorder is characterized by a recurrent or persistent difficulty in achieving orgasm during sexual activity. A study of sexual activity in a representative sample of the US population ages 18-59 found that 24% of US females complained of significant difficulty achieving orgasm in the preceding year (Laumann et al, 2000). Epidemiological studies in Sweden and the United Kingdom have found similar rates of orgasm disorder. Studies of drugs with actions of increasing genital vasodilation in response to sexual stimulation (eg alprostadil, sildenafil, or phentolamine) have generally been found to be unsuccessful or to have extremely limited efficacy in reversing female sexual dysfunction (Basson, 2001; Segraves, 2002). High doses of androgen have been shown to increase various parameters of sexual interest and activity in women after hysterectomy and bilateral oophorectomy (Schifren et al, 2000) and there is some evidence that oral dehydroepiandrosterone may increase responsiveness to sexual stimuli in postmenopausal women (Hackbert & Heiman, 2002). There have been fewer studies of pharmacological treatment for hypoactive sexual desire disorder in premenopausal women. Extensive literature indicates that bupropion has a very low incidence of drug-induced sexual dysfunction (Clayton et al, 2002; Croft et al, 1999; Segraves & Balon, 2003) and that bupropion may reverse sexual dysfunction associated with serotonergic antidepressants (Rosen et al, 1999; Kennedy et al, 2002). In addition one controlled study (Crenshaw et al, 1987) and several clinical series indicate that bupropion may have prosexual effects in non-depressed females (Modell et al, 2000). A single blind study (Segraves et al, 2001) found that bupropion increased the frequency of episodes of sexual arousal and desire for sexual activity in women diagnosed with hypoactive sexual desire disorder. A recent multicenter, double-blind, fixed dose study of females with global, acquired hypoactive sexual desire disorder found evidence that an exposure to 300 to 400 mg bupropion XL increased orgasm and pleasure as measured by the CSFQ-F. In this pilot study, all women had total serum testosterone levels within normal limits and were in stable, non-conflictual relationships. All patients had no evidence of psychiatric disorder and no evident etiology to their sexual complaint. All were pre-menopausal. The pilot study observed the effects of drug treatment for four months. Significant change in measures of sexual orgasm occurred as early as day 28. There are no currently approved pharmacological treatments for women with orgasmic disorder. Specific Aims: The purpose of this study is to delineate the effects of bupropion XL in women with global orgasmic disorder, using double blind conditions in an 8 week flexible dose multisite comparison of bupropion XL and placebo. It is hypothesized that bupropion XL will increase orgasm completion. 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. Secondary objectives will be to investigate the effects of bupropion XL on changes in sexual arousal and sexual pleasure. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Orgasmic Disorder | |||
Intervention ICMJE | Drug: Wellbutrin XL
Patients 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.
Other Name: bupropion XL, Wellbutrin XL |
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Study Arms | Placebo Comparator: Wellbutrin XL or placebo
1 arms - Wellbutrin XL or placebo
Intervention: Drug: Wellbutrin XL |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
48 | |||
Original Enrollment ICMJE |
80 | |||
Actual Study Completion Date | April 2007 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: A subject must:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00248209 | |||
Other Study ID Numbers ICMJE | GSK FOD | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Segraves, R.T. M.D., Ph.D, MetroHealth Medical Center | |||
Study Sponsor ICMJE | Segraves, R., T., M.D., Ph.D. | |||
Collaborators ICMJE | GlaxoSmithKline | |||
Investigators ICMJE |
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PRS Account | Segraves, R., T., M.D., Ph.D. | |||
Verification Date | April 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |