Female Orgasmic Disorder (FOD) and Wellbutrin XL

NCT00248209 | Completed Phase 2

• 1 other identifier: GSK FOD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Orgasmic Disorder

Keywords

Female Orgasmic Disorder; Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary objectives will be to investigate the effects of bupropion XL on changes in sexual arousal and sexual pleasure.

  8 weeks of treatment

Study Arms (1)

Wellbutrin XL or placebo

PLACEBO COMPARATOR

1 arms - Wellbutrin XL or placebo

Drug: Wellbutrin XL

Interventions

Wellbutrin XL DRUG

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.

Also known as: bupropion XL, Wellbutrin XL

Wellbutrin XL or placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A subject must:
• Be able to understand and sign a written informed consent
• Be a premenopausal female between 20 and 50 years of age, inclusive
• Use active birth control, and be non-lactating, with a negative urine pregnancy test
• Have no evidence of mood or anxiety disorder
• Have a sexual partner who is without sexual dysfunction
• Be in a stable, monogamous, sexual relationship of at least 6 months duration, and be willing to engage in sexual activity with a steady partner once a week for the duration of the study
• Have no active psychiatric diagnosis
• Have FOD which is not secondary to hypoactive sexual desire disorder or dyspareunia
• Have English as first language or be fluent in English language
• Meet operational definition of global female orgasmic disorder:
• Frequency of orgasm during sexual activity of less than 50% of sexual encounters
• Presence of disorder for at least six months
• At least 3 orgasms achieved in past 6 months
• Have Beck Anxiety Disorder (BAI) scores less than 10

You may not qualify if:

• Presence of organic condition known to cause sexual dysfunction (multiple sclerosis, diabetes mellitus, spinal cord injury)
• Presence of hypoactive sexual desire disorder as defined below:
• Frequency of subjective sexual desire (interest in any type of sexual activity) less than or equal to once every two weeks
• Low intensity of sexual desire
• Frequency of self-initiated sexual activity less than or equal to once every two weeks
• Absence or low frequency of thoughts about sex (do not include thoughts of wishing for return of sexual interest): thoughts less than or equal to 4 times per month
• Presence of disorder for at least six months
• Absence of sexual desire includes all types of sexual activity
• Taking psychiatric drugs other than study medication (zolpidem can be taken for a total of 10 days in trial for nighttime sedation)
• Significant marital discord
• Presence of sexual aversion disorder, dyspareunia, vaginismus, gender identity disorder, paraphilia
• Drug or alcohol abuse in past year
• History of seizure disorder or significant head injury
• History of anorexia or bulimia
• Taking any pharmacological agents known to be associated with sexual dysfunction (chronic opiate use, beta-blockers, alpha-adrenergic blockers, psychotropic medications)

Sponsors & Collaborators

• Segraves, R., T., M.D., Ph.D.: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Robert T Segraves, MD, PhD

  MetroHealth Medical Center/Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 3, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 20, 2011

Record last verified: 2007-04

Locations

US (1)