Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret Altemus, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00611975
First received: February 6, 2008
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Fluoxetine
Drug: Bupropion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 17-OH-pregnenolone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arizona Sexual Experiences Scale (ASEX) [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Free testosterone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Estradiol [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Prolactin [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Progesterone [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Dehydroepiandrosterone Sulfate (DHEA-S) [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Androstenedione [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Inflammatory cytokines [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • Lymphocyte activation markers [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2005
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prozac, Serafem
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 Name: Wellbutrin, Zyban

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 IUD, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611975

Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Margaret Altemus, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Margaret Altemus, Associate Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00611975     History of Changes
Other Study ID Numbers: R21 MH071543, R21MH071543, DNBBS 73-MCR
Study First Received: February 6, 2008
Last Updated: June 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Gonadal Steroid Hormones
Healthy Volunteers
Antidepressant Side Effects
Fluoxetine
Bupropion
Prolactin
Testosterone
Estradiol
Progesterone
Sexual Function
Serotonin Reuptake Inhibitors
17-OH Pregnenolone

Additional relevant MeSH terms:
Antidepressive Agents
Fluoxetine
Bupropion
Serotonin Uptake Inhibitors
Hormones
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Hormones, Hormone Substitutes, and Hormone Antagonists
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on July 26, 2014