Status:
COMPLETED
Female Orgasmic Disorder (FOD) and Wellbutrin XL
Lead Sponsor:
Segraves, R., T., M.D., Ph.D.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Orgasmic Disorder
Eligibility:
FEMALE
20-50 years
Phase:
PHASE2
PHASE3
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 hyp...
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 ...
Eligibility Criteria
Inclusion
- 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
- Have Beck Depression Inventory-II (BDI-II) scores less than 10
- Have a CSFQ orgasm score of less than 11
- Patient may have female arousal disorder as well as female orgasmic disorder
Exclusion
- 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)
- Have an onset of orgasmic disorder within two months of beginning current hormonal contraceptive agent, if applicable
- Have a cessation of menses for the three consecutive months prior to study entry
- History of bilateral oophorectomy
- Presence of dyspareunia
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00248209
Start Date
May 1 2004
End Date
April 1 2007
Last Update
July 20 2011
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109