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

• ClinicalTrials.gov Identifier: NCT01702818
• Recruitment Status: Completed
• First Posted: October 8, 2012
• Last Update Posted: October 17, 2018
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): Lori Brotto, University of British Columbia

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 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
• Actual Enrollment: 324 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Stress Hormones, Mood and Women's Sexual Desire (MODEST)
• Study Start Date: February 2012
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Groups and Cohorts

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).

Outcome Measures

Primary Outcome Measures :

1. DHEA levels [ Time Frame: Data is collected at 4 time points on 3 separate days ]
   DHEA levels derived from saliva samples.

Secondary Outcome Measures :

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)

Biospecimen Retention:   Samples Without DNA

saliva samples

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 65 Years (Adult, Older 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).

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.

Contacts and Locations

Locations

Canada, British Columbia

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, Canada, V6T 1Z9

Sponsors and Collaborators

University of British Columbia

Investigators

• Principal Investigator: Rosemary Basson, MD; University of British Columbia
• Principal Investigator: Lori A Brotto, PhD; University of British Columbia

More Information

Additional Information:

UBC Sexual Health Lab 

• Responsible Party: Lori Brotto, Associate Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01702818
• Other Study ID Numbers: H10-02067
• First Posted: October 8, 2012
• Last Update Posted: October 17, 2018
• Last Verified: May 2017

Keywords provided by Lori Brotto, University of British Columbia:

Hypoactive Sexual Desire Disorder; HSDD; Cortisol; DHEA; Stress Hormones; Sexual Desire; Mood; Sexual Function; Childhood Maltreatment; Childhood Abuse

Additional relevant MeSH terms:

Hypokinesia; Sexual Dysfunctions, Psychological; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Mental Disorders