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

NCT01702818 | Completed

• 1 other identifier: H10-02067
• Study Type: observational
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Sexual Desire Disorder (HSDD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• DHEA levels

  DHEA levels derived from saliva samples.

  Data is collected at 4 time points on 3 separate days

Secondary Outcomes (8)

• Cortisol levels

  Data is collected at 4 time points on 3 separate days

• Depression

  data is collected at single time point

• Perceived stress

  data is collected at a single time point

• Sexual function

  data is collected at a single time point

• Relationship satisfaction

  data is collected at a single time point

Study Arms (2)

HSDD group

Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Control Group

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

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (1) diagnosis of HSDD
• (2) over 19 years of age
• (3) sexual complaints of low desire of at least 12 months duration.
• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, V6T 1Z9, Canada

Location

Related Links

• UBC Sexual Health Lab

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva samples

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rosemary Basson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Lori A Brotto, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: October 8, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 17, 2018

Record last verified: 2017-05

Locations

CA (1)