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Completed

NCT Number: NCT01189825

Efficacy of Exercise for Sexual Side Effects of Antidepressants

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Behavioral

Moderate to intense cardiovascular exercise on a treadmill for 20 minutes

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effects of Acute Exercise on Sexual Arousal in Women Taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Serotonin/Norepinephrine Reuptake Inhibitor

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 27, 2010
Registry last updated
Feb 27, 2013

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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