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Efficacy of Exercise for Sexual Side Effects of Antidepressants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189825
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : February 27, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tierney Kyle Ahrold Lorenz, University of Texas at Austin

Brief Summary:
The major aim of the this study is to replicate findings of previous research that examined the effects of acute exercise on sexual arousal in women in a novel population, namely, women taking antidepressants of the selective serotonin reuptake inhibitors (SSRI) or selective serotonin and norepinephrine reuptake inhibitors (SNRI) class. In previous studies it has been found that acute, moderate-intensity exercise facilitated physiological sexual arousal responses in healthy, sexually functional women. However, it is known that antidepressants may induce sexual dysfunction, and thus in the present study, the investigators are examining whether acute exercise may facilitate sexual responses in women with taking antidepressants, including women with antidepressant-related sexual dysfunction.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Acute Exercise on Sexual Arousal in Women Taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Serotonin/Norepinephrine Reuptake Inhibitor
Study Start Date : June 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise Behavioral: Exercise
Moderate to intense cardiovascular exercise on a treadmill for 20 minutes




Primary Outcome Measures :
  1. Sexual arousal [ Time Frame: 5 & 15 minutes post exercise ]
    Arousal to sexually explicit stimuli will be measured in the laboratory using a vaginal photoplethysmograph.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female
  • age 18 or older
  • currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine
  • currently sexually active
  • willing and able to exercise
  • experiencing regular menstrual cycles
  • not currently pregnant and not intending to become pregnant during trial

Exclusion Criteria:

  • currently taking more than one psychoactive medication
  • factors indicating risk of cardiovascular activity, including acute or chronic cardiovascular illness, including clinically significant hypertension (defined as self-reported hypertension or "blood pressure greater than 140/90" or receiving medications designed to treat hypertension); recent chest pain; frequent or recurrent faint or dizzy spells; severe or untreated exercise-related asthma; or musculoskeletal illness or injury that would be expected to worsen with physical exercise. Additionally, women will be excluded if they are found to have any of the following as measured during the fitness assessment of the first session: a BMI over 40, waist circumference over 40 inches, waist-to-hip ratio of greater than 0.9, systolic blood pressure greater than 150 or diastolic pressure over 95, or resting heart rate over 90.
  • factors associated with significant genital nerve damage, including: previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
  • factors associated with non-normative endocrine function, including: perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or reporting clinically significant untreated renal or endocrine disease
  • untreated serious mental health conditions
  • sexual aversion or distress due to history of unwanted sexual contact

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189825


Locations
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United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Tierney K Ahrold Lorenz, M.A. University of Texas at Austin

Additional Information:
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Responsible Party: Tierney Kyle Ahrold Lorenz, Researcher, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01189825    
Other Study ID Numbers: 2007-12-0059
1F31MH085416-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013
Keywords provided by Tierney Kyle Ahrold Lorenz, University of Texas at Austin:
Physiological
Antidepressive Agents