Overview

This trial is active, not recruiting.

Condition hypoactive sexual desire disorder (hsdd).
Sponsor University of British Columbia
Start date February 2012
End date November 2016
Trial size 320 participants
Trial identifier NCT01702818, H10-02067

Summary

Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although DHEA is a precursor of testosterone it has other actions including involvement in the stress system. It is also linked to mood. This study focuses on measures of childhood stress, current mood and salivary and nail stress hormones, in women with and without HSDD. We hypothesize that low levels of DHEA reflect dysfunction of the neuroendocrine stress response system involving the brain, pituitary and adrenal glands where DHEA is produced.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective cross-sectional
Arm
Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Primary Outcomes

Measure
DHEA levels
time frame: data is collected at a single time point

Secondary Outcomes

Measure
Cortisol levels
time frame: data is collected at a single time point
Depression
time frame: data is collected at single time point
Perceived stress
time frame: data is collected at a single time point
Sexual function
time frame: data is collected at a single time point
Relationship satisfaction
time frame: data is collected at a single time point
History of childhood trauma
time frame: dat is collected at a single timepoint
History of childhood sexual abuse
time frame: data is collected at a single time point
PTSD symptoms
time frame: data is collected at a single time point

Eligibility Criteria

Female participants from 19 years up to 65 years old.

Inclusion Criteria for HSDD Group: - (1) diagnosis of HSDD - (2) over 19 years of age - (3) sexual complaints of low desire of at least 12 months duration. Inclusion criteria for Control group: - (1) sexually healthy, i.e., must not meet criteria for any sexual dysfunction, as determined by a telephone screening, followed by an in-person structured assessment, the Decreased Sexual Desire Screener (DSDS) - (2) over 19 years of age. Exclusion Criteria for both Control and HSDD groups: - (1) lack of fluency in English - (2) currently meeting DSM-IV-TR diagnostic criteria for major depressive disorder as measured by an in-person, semi-structured interview based on the Major Depressive Disorder Module of the Structured Clinical Interview for DSM-IV-TR (SCID-I - (3) current use of prescription drugs such as antidepressants or other medications with known sexual side effects (e.g., glucocorticoids, aromatase inhibitors), or known effects on cortisol metabolism, or use of illicit drugs - (4) use of hormone replacement therapy or hormonal contraceptives; - (5) a body mass index (BMI) <18.5 or >29.9 - (6) cigarette smoking - (7) chronic medical or psychiatric disease with potential to interfere with sexual function (e.g., chronic neurological disease, cardiac and liver disease, eating disorders, anxiety disorders) - (8) chronic pain with intercourse not relieved by a vaginal lubricant - (9) loss of genital responsiveness - (10) significant relationship discord - (11) not having a family physician who we could contact if depression is diagnosed during the assessment - (12) difficulty in complying with questionnaires or in completing interview.

Additional Information

Official title Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Principal investigator Rosemary Basson, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.