Trial record 10 of 89 for:
Open Studies | "Sexual Dysfunctions, Psychological"
Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Verified June 2015 by University of British Columbia
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia
First received: August 27, 2012
Last updated: June 11, 2015
Last verified: June 2015
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.
Hypoactive Sexual Desire Disorder (HSDD).
||Time Perspective: Cross-Sectional
||Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Primary Outcome Measures:
Biospecimen Retention: Samples Without DNA
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)
saliva and fingernail and toenail samples
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2016 (Final data collection date for primary outcome measure)
Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
|Ages Eligible for Study:
||19 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01702818
|British Columbia Centre for Sexual Medicine
|Vancouver, British Columbia, Canada, V6T 1Z9 |
|Contact: Melissa H Moses, BA 604-827-1311 email@example.com |
|Contact: Lori A Brotto, PhD 604-875-4111 ext 68898 firstname.lastname@example.org |
|Sub-Investigator: Lori A Brotto, PhD |
University of British Columbia
||Rosemary Basson, MD
||University of British Columbia
No publications provided
||Lori Brotto, Associate Professor, University of British Columbia
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 27, 2012
||June 11, 2015
||Canada: Ethics Review Committee
Keywords provided by University of British Columbia:
Hypoactive Sexual Desire Disorder
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015
Sexual Dysfunctions, Psychological
Nervous System Diseases
Sexual and Gender Disorders
Signs and Symptoms