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

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder (HSDD)

• Study Type: Observational
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z9
      • British Columbia Centre for Sexual Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DHEA levels	DHEA levels derived from saliva samples.	Data is collected at 4 time points on 3 separate days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol levels	Cortisol levels derived from saliva samples.	Data is collected at 4 time points on 3 separate days
Depression	Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)	data is collected at single time point
Perceived stress	Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington & Storch 2006)	data is collected at a single time point
Sexual function	Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))	data is collected at a single time point
Relationship satisfaction	Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)	data is collected at a single time point
History of childhood trauma	History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein & Fink, 1995)	dat is collected at a single timepoint
History of childhood sexual abuse	History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)	data is collected at a single time point
PTSD symptoms	Presence and severity of post traumatic stress disorder symptoms will be determined through the Clinician-Administered PTSD Scale (Blake et al. 1998)	data is collected at a single time point

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Rosemary Basson, MD, University of British Columbia

Publications and helpful links

Helpful Links

• UBC Sexual Health Lab

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: August 27, 2012
• First Submitted That Met QC Criteria: October 5, 2012
• First Posted (ESTIMATE): October 8, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: DHEA; Cortisol; Sexual Desire; HSDD; Mood; Hypoactive Sexual Desire Disorder; Sexual Function; Childhood Maltreatment; Stress Hormones; Childhood Abuse
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Hypokinesia; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: H10-02067