Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect of antidepressants on sex hormone levels in women and if
      the potential changes in sex hormone levels are related to sexual side effects.
    

Detailed description: 
      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.
    

Intervention name(s): Fluoxetine; Bupropion
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Prozac, Sarafem; Wellbutrin, Zyban
Intervention MeSH terms: Bupropion; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Gonadal Steroid Hormones; Healthy Volunteers; Antidepressant Side Effects; Fluoxetine; Bupropion; Prolactin; Testosterone; Estradiol; Progesterone; Sexual Function; Serotonin Reuptake Inhibitors; 17-OH Pregnenolone