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CompletedNCT01702818MODESTUpdated Oct 17, 2018

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

An observational study in Hypoactive Sexual Desire Disorder (HSDD), sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-17.

Sponsored by University of British Columbia · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
324
Ages
19 Years to 65 Years
Sex
Female
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Study 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 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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Conditions studied

  • Hypoactive Sexual Desire Disorder (HSDD)

Keywords

  • Hypoactive Sexual Desire Disorder
  • HSDD
  • Cortisol
  • DHEA
  • Stress Hormones
  • Sexual Desire
  • Mood
  • Sexual Function
  • Childhood Maltreatment
  • Childhood Abuse
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In context

Hypokinesia

84 studies on the registry are indexed under Hypokinesia; 10 are open to participants now.

This study's enrollment of 324 is above the median of 253 across 16 observational studies indexed under Hypokinesia.

Browse Hypokinesia studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Eligibility criteria

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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
324 participants (actual)
Biospecimen retention
Samples without dna

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).

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What researchers measure

Primary outcomes

  1. DHEA levels

    DHEA levels derived from saliva samples.

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

Secondary outcomes

  1. Cortisol levels

    Cortisol levels derived from saliva samples.

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

  2. Depression

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

    Time frame: data is collected at single time point

  3. Perceived stress

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

    Time frame: data is collected at a single time point

  4. Sexual function

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

    Time frame: data is collected at a single time point

  5. Relationship satisfaction

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

    Time frame: data is collected at a single time point

  6. History of childhood trauma

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

    Time frame: dat is collected at a single timepoint

  7. History of childhood sexual abuse

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

    Time frame: data is collected at a single time point

  8. PTSD symptoms

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

    Time frame: data is collected at a single time point

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Study locations

1 site
  • British Columbia Centre for Sexual Medicine
    Vancouver, British Columbia V6T 1Z9, Canada
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01702818
Lead sponsor
University of British Columbia
Responsible party
Lori Brotto (Associate Professor, University of British Columbia) — Principal investigator
First posted
Oct 8, 2012
Start date
Feb 2012
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Oct 17, 2018

Study contacts

Rosemary Basson, MD
principal investigator · University of British Columbia
Lori A Brotto, PhD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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