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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01702818
First received: August 27, 2012
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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 and nail 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
Hypoactive Sexual Desire Disorder (HSDD).

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Stress Hormones, Mood and Women's Sexual Desire (MODEST)

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • DHEA levels [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    DHEA levels derived from both finger and toenail samples.


Secondary Outcome Measures:
  • Cortisol levels [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    Cortisol levels derived from saliva samples.

  • Depression [ Time Frame: data is collected at single time point ] [ Designated as safety issue: No ]
    Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)

  • Perceived stress [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington & Storch 2006)

  • Sexual function [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))

  • Relationship satisfaction [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)

  • History of childhood trauma [ Time Frame: dat is collected at a single timepoint ] [ Designated as safety issue: No ]
    History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein & Fink, 1995)

  • History of childhood sexual abuse [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)

  • PTSD symptoms [ Time Frame: data is collected at a single time point ] [ Designated as safety issue: No ]
    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 and fingernail and toenail samples


Estimated Enrollment: 320
Study Start Date: February 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/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).

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702818

Contacts
Contact: Melissa H Moses, BA 604-875-8258 melissa.moses@vch.ca
Contact: Lori A Brotto, PhD 604-875-4111 ext 68898 lori.brotto@vch.ca

Locations
Canada, British Columbia
British Columbia Centre for Sexual Medicine Recruiting
Vancouver, British Columbia, Canada, V5Z 1C6
Contact: Melissa H Moses, BA    604-875-8258    melissa.moses@vch.ca   
Contact: Lori A Brotto, PhD    604-875-4111 ext 68898    lori.brotto@vch.ca   
Sub-Investigator: Lori A Brotto, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Rosemary Basson, MD University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: Lori Brotto, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT01702818     History of Changes
Other Study ID Numbers: H10-02067
Study First Received: August 27, 2012
Last Updated: October 5, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Sexual and Gender Disorders
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014