Effect of Antidepressants on Sex Hormone Levels and Sexual Functioning

NCT00611975 | Completed Phase 4 Results

• 2 other identifiers: R21MH071543DNBBS 73-MCR
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

Gonadal Steroid Hormones; Healthy Volunteers; Antidepressant Side Effects; Fluoxetine; Bupropion; Prolactin; Testosterone; Estradiol; Progesterone; Sexual Function; Serotonin Reuptake Inhibitors; 17-OH Pregnenolone

Outcome Measures

Primary Outcomes (1)

• Change in 17-OH Pregnenolone

  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 Outcomes (10)

• Change in Arizona Sexual Experiences Scale (ASEX)

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

• Change in Free Testosterone

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

• Change in Estradiol

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

• Change in Prolactin

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

• Change in Progesterone

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

Study Arms (2)

A

EXPERIMENTAL

Participants will receive treatment with fluoxetine for 2 months

Drug: Fluoxetine

B

EXPERIMENTAL

Participants will receive treatment with bupropion for 2 months

Drug: Bupropion

Interventions

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.

Also known as: Prozac, Sarafem

A

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.

Also known as: Wellbutrin, Zyban

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Interventions

Fluoxetine; Bupropion

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Propiophenones; Ketones

Results Point of Contact

• Title: Margaret Altemus
• Organization: Yale School of Medicine

margaret.altemus@yale.edu

646-209-6277

Study Officials

• Margaret Altemus, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 11, 2008
• Study Start: October 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11