Female Orgasmic Disorder (FOD) and Wellbutrin XL
Condition: Orgasmic Disorder
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Wellbutrin XL
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): bupropion XL, Wellbutrin XL
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Female Orgasmic Disorder; Female Sexual Dysfunction