Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
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|ClinicalTrials.gov Identifier: NCT00611975|
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : June 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Fluoxetine Drug: Bupropion||Phase 4|
Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or more of the antidepressant medications and forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of antidepressants that have been successful in alleviating symptoms of depression. Although the side effects of SRIs are less than those of other types of antidepressants, a number of people taking SRIs experience sexual dysfunction, including reduced desire and difficulty with orgasm. It is believed that SRI treatment may interfere with gonadal production of steroid hormones, thus leading to changes in sexual function. This study will compare the effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels of sex hormones in healthy women and on any related sexual side effects.
Participation in this study will last 3 months. Potential participants will undergo initial screening, which will involve a blood draw, drug and pregnancy tests, physical exam, electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an interview and questionnaire about sexual functioning. All eligible participants will then be asked to return for a total of 9 study visits over 3 months.
Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily treatment with either fluoxetine or bupropion. The study visits will be scheduled around three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each visit including a blood draw and repeat questionnaire on sexual functioning. Participants will be asked to perform daily urine tests, beginning 10 days after the start of menstruation and continuing for up to 8 days until detection of the luteinizing hormone surge, which signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges, dates of menstruation, and sexual activities. At the Month 3 visit, participants will discontinue their assigned medication and will complete their final blood draw and questionnaire.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||September 2008|
Participants will receive treatment with fluoxetine for 2 months
Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine.
Other Name: Prozac, Serafem
Participants will receive treatment with bupropion for 2 months
Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.
Other Name: Wellbutrin, Zyban
- 17-OH-pregnenolone [ Time Frame: Measured at Month 3 ]
- Arizona Sexual Experiences Scale (ASEX) [ Time Frame: Measured at Month 3 ]
- Free testosterone [ Time Frame: Measured at Month 3 ]
- Estradiol [ Time Frame: Measured at Month 3 ]
- Prolactin [ Time Frame: Measured at Month 3 ]
- Progesterone [ Time Frame: Measured at Month 3 ]
- Dehydroepiandrosterone Sulfate (DHEA-S) [ Time Frame: Measured at Month 3 ]
- Androstenedione [ Time Frame: Measured at Month 3 ]
- C-reactive protein [ Time Frame: Measured at Month 3 ]
- Inflammatory cytokines [ Time Frame: Measured at Month 3 ]
- Lymphocyte activation markers [ Time Frame: Measured at Month 3 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00611975
|Principal Investigator:||Margaret Altemus, MD||Weill Medical College of Cornell University|