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Completed

NCT Number: NCT00611975

Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry
  • Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
  • Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration of the study

Exclusion criteria

  • Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels
  • Body mass index (BMI) greater than 30
  • Elevated testosterone at screening
  • History of seizure disorder
  • Consumes more than 10 alcoholic beverages per week

Treatment and study plan

Fluoxetine

Drug

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 names: Prozac, Sarafem

bupropion

Drug

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 names: Wellbutrin, Zyban

Primary outcomes

  1. Change in 17-OH Pregnenolone

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone level were examined.

Secondary outcomes

  1. Change in Arizona Sexual Experiences Scale (ASEX)

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    A five-item scale with each item scored from 1 to 6. Score range is 5 to 30. Higher scores indicate more sexual dysfunction.

    Scores at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on ASEX scores were examined.

  2. Change in Free Testosterone

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Free testosterone was calculated from total testosterone ng/ml divided by sex hormone binding globulin (SHBG) nmol/l multiplied by 100. Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.

  3. Change in Estradiol

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.

  4. Change in Prolactin

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.

  5. Change in Progesterone

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Hormone levels at early follicular, ovulation, and luteal phase of the cycle were averaged for the baseline pre-treatment month and compared to average values during the 1st and 2nd months of antidepressant treatment.

  6. Change in Dehydroepiandrosterone Sulfate (DHEA-S)

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.

  7. Change in Androstenedione

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

    Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline month, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Differential effects of the two antidepressant treatments and menstrual cycle on hormone levels were examined.

  8. C-reactive Protein

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

  9. Inflammatory Cytokines

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

  10. Lymphocyte Activation Markers

    Time frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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