Female Orgasmic Disorder (FOD) and Wellbutrin XL

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Segraves, R., T., M.D., Ph.D.
• Collaborator: GlaxoSmithKline
• Treatments: Bupropion

Criteria

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 disorder

5. Have a sexual partner who is without sexual dysfunction

6. 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

7. Have no active psychiatric diagnosis

8. Have FOD which is not secondary to hypoactive sexual desire disorder or dyspareunia

9. Have English as first language or be fluent in English language

10. Meet operational definition of global female orgasmic disorder:

1. Frequency of orgasm during sexual activity of less than 50% of sexual encounters

2. Presence of disorder for at least six months

3. At least 3 orgasms achieved in past 6 months

11. Have Beck Anxiety Disorder (BAI) scores less than 10

12. Have Beck Depression Inventory-II (BDI-II) scores less than 10

13. Have a CSFQ orgasm score of less than 11

14. Patient may have female arousal disorder as well as female orgasmic disorder

Exclusion Criteria:

1. Presence of organic condition known to cause sexual dysfunction (multiple sclerosis, diabetes mellitus, spinal cord injury)

2. Presence of hypoactive sexual desire disorder as defined below:

1. Frequency of subjective sexual desire (interest in any type of sexual activity) less than or equal to once every two weeks

2. Low intensity of sexual desire

3. Frequency of self-initiated sexual activity less than or equal to once every two weeks

4. 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

5. Presence of disorder for at least six months

6. Absence of sexual desire includes all types of sexual activity

3. Taking psychiatric drugs other than study medication (zolpidem can be taken for a total of 10 days in trial for nighttime sedation)

4. Significant marital discord

5. Presence of sexual aversion disorder, dyspareunia, vaginismus, gender identity disorder, paraphilia

6. Drug or alcohol abuse in past year

7. History of seizure disorder or significant head injury

8. History of anorexia or bulimia

9. Taking any pharmacological agents known to be associated with sexual dysfunction (chronic opiate use, beta-blockers, alpha-adrenergic blockers, psychotropic medications)

10. Have an onset of orgasmic disorder within two months of beginning current hormonal contraceptive agent, if applicable

11. Have a cessation of menses for the three consecutive months prior to study entry

12. History of bilateral oophorectomy

13. Presence of dyspareunia