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

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: NCT01702818
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Hypoactive Sexual Desire Disorder (HSDD)

Study Design

Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Study Start Date : February 2012
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Groups and Cohorts

HSDD group
Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Control Group
Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Outcome Measures

Primary Outcome Measures :
  1. DHEA levels [ Time Frame: data is collected at a single time point ]
    DHEA levels derived from both finger and toenail samples.

Secondary Outcome Measures :
  1. Cortisol levels [ Time Frame: data is collected at a single time point ]
    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)

Biospecimen Retention:   Samples Without DNA
saliva and fingernail and toenail samples

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

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.
Contacts and Locations

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): NCT01702818

Canada, British Columbia
British Columbia Centre for Sexual Medicine
Vancouver, British Columbia, Canada, V6T 1Z9
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Rosemary Basson, MD University of British Columbia
More Information

Responsible Party: Lori Brotto, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01702818     History of Changes
Other Study ID Numbers: H10-02067
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017

Keywords provided by Lori Brotto, University of British Columbia:
Hypoactive Sexual Desire Disorder
Stress Hormones
Sexual Desire
Sexual Function
Childhood Maltreatment
Childhood Abuse

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs