Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning

November 16, 2020 updated by: Weill Medical College of Cornell University

Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Participants will receive treatment with fluoxetine for 2 months
Drug: Fluoxetine
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
Experimental: B
Participants will receive treatment with bupropion for 2 months
Drug: Bupropion
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
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.
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
C-reactive Protein
Time Frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Inflammatory Cytokines
Time Frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Lymphocyte Activation Markers
Time Frame: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Actual)

December 10, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH071543 (U.S. NIH Grant/Contract)
  • DNBBS 73-MCR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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