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

Hypoactive Sexual Desire Disorder (HSDD) Clinical Trial

— MODEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702818
• Other study ID #: H10-02067
• Status: Completed
• Start date: February 2012
• Est. completion date: November 2016

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder (HSDD)
• Hypokinesia
• Sexual Dysfunctions, Psychological

Locations

Country	Name	City	State
Canada	British Columbia Centre for Sexual Medicine	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DHEA levels	DHEA levels derived from saliva samples.	Data is collected at 4 time points on 3 separate days
Secondary	Cortisol levels	Cortisol levels derived from saliva samples.	Data is collected at 4 time points on 3 separate days
Secondary	Depression	Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)	data is collected at single time point
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   UBC Sexual Health Lab