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Completed

NCT Number: NCT01702818

Stress Hormones, Mood and Women's Sexual Desire (MODEST)

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 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.

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Key information

Age range

19 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, V6T 1Z9, Canada

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. DHEA levels

    Time frame: Data is collected at 4 time points on 3 separate days

    DHEA levels derived from saliva samples.

Secondary outcomes

  1. Cortisol levels

    Time frame: Data is collected at 4 time points on 3 separate days

    Cortisol levels derived from saliva samples.

  2. Depression

    Time frame: data is collected at single time point

    Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)

  3. Perceived stress

    Time frame: data is collected at a single time point

    Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington & Storch 2006)

  4. Sexual function

    Time frame: data is collected at a single time point

    Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))

  5. Relationship satisfaction

    Time frame: data is collected at a single time point

    Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)

  6. History of childhood trauma

    Time frame: dat is collected at a single timepoint

    History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein & Fink, 1995)

  7. History of childhood sexual abuse

    Time frame: data is collected at a single time point

    History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)

  8. PTSD symptoms

    Time frame: data is collected at a single time point

    Presence and severity of post traumatic stress disorder symptoms will be determined through the Clinician-Administered PTSD Scale (Blake et al. 1998)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: MODEST

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2012
Registry last updated
Oct 17, 2018

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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