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

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

Tracking Information
First Submitted Date August 27, 2012
First Posted Date October 8, 2012
Last Update Posted Date October 17, 2018
Study Start Date February 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2018)
DHEA levels [ Time Frame: Data is collected at 4 time points on 3 separate days ]
DHEA levels derived from saliva samples.
Original Primary Outcome Measures
 (submitted: October 5, 2012)
DHEA levels [ Time Frame: data is collected at a single time point ]
DHEA levels derived from both finger and toenail samples.
Change History Complete list of historical versions of study NCT01702818 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 15, 2018)
  • Cortisol levels [ Time Frame: Data is collected at 4 time points on 3 separate days ]
    Cortisol levels derived from saliva samples.
  • Depression [ Time Frame: data is collected at single time point ]
    Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)
  • 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)
  • 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))
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures
 (submitted: October 5, 2012)
  • Cortisol levels [ Time Frame: data is collected at a single time point ]
    Cortisol levels derived from saliva samples.
  • Depression [ Time Frame: data is collected at single time point ]
    Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)
  • 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)
  • 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))
  • 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)
  • 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)
  • 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)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Official Title Stress Hormones, Mood and Women's Sexual Desire (MODEST)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
saliva samples
Sampling Method Non-Probability Sample
Study Population Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Condition Hypoactive Sexual Desire Disorder (HSDD)
Intervention Not Provided
Study 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2018)
324
Original Estimated Enrollment
 (submitted: October 5, 2012)
320
Actual Study Completion Date November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01702818
Other Study ID Numbers H10-02067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lori Brotto, University of British Columbia
Study Sponsor University of British Columbia
Collaborators Not Provided
Investigators
Principal Investigator: Rosemary Basson, MD University of British Columbia
Principal Investigator: Lori A Brotto, PhD University of British Columbia
PRS Account University of British Columbia
Verification Date May 2017