Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT01702818
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2012-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'saliva samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 324}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2012-08-27', 'studyFirstSubmitQcDate': '2012-10-05', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DHEA levels', 'timeFrame': 'Data is collected at 4 time points on 3 separate days', 'description': 'DHEA levels derived from saliva samples.'}], 'secondaryOutcomes': [{'measure': 'Cortisol levels', 'timeFrame': 'Data is collected at 4 time points on 3 separate days', 'description': 'Cortisol levels derived from saliva samples.'}, {'measure': 'Depression', 'timeFrame': 'data is collected at single time point', 'description': 'Depression will be measured by the Beck Depression Inventory (Beck \\& Beamesderfer, 1974)'}, {'measure': 'Perceived stress', 'timeFrame': 'data is collected at a single time point', 'description': 'Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington \\& Storch 2006)'}, {'measure': 'Sexual function', 'timeFrame': 'data is collected at a single time point', 'description': 'Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))'}, {'measure': 'Relationship satisfaction', 'timeFrame': 'data is collected at a single time point', 'description': 'Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)'}, {'measure': 'History of childhood trauma', 'timeFrame': 'dat is collected at a single timepoint', 'description': 'History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein \\& Fink, 1995)'}, {'measure': 'History of childhood sexual abuse', 'timeFrame': 'data is collected at a single time point', 'description': 'History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)'}, {'measure': 'PTSD symptoms', 'timeFrame': 'data is collected at a single time point', 'description': 'Presence and severity of post traumatic stress disorder symptoms will be determined through the Clinician-Administered PTSD Scale (Blake et al. 1998)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypoactive Sexual Desire Disorder', 'HSDD', 'Cortisol', 'DHEA', 'Stress Hormones', 'Sexual Desire', 'Mood', 'Sexual Function', 'Childhood Maltreatment', 'Childhood Abuse'], 'conditions': ['Hypoactive Sexual Desire Disorder (HSDD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://brottolab.med.ubc.ca/', 'label': 'UBC Sexual Health Lab'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for HSDD Group:\n\n* (1) diagnosis of HSDD\n* (2) over 19 years of age\n* (3) sexual complaints of low desire of at least 12 months duration.\n\nInclusion criteria for Control group:\n\n* (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)\n* (2) over 19 years of age.\n\nExclusion Criteria for both Control and HSDD groups:\n\n* (1) lack of fluency in English\n* (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\n* (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\n* (4) use of hormone replacement therapy or hormonal contraceptives;\n* (5) a body mass index (BMI) \\<18.5 or \\>29.9\n* (6) cigarette smoking\n* (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)\n* (8) chronic pain with intercourse not relieved by a vaginal lubricant\n* (9) loss of genital responsiveness\n* (10) significant relationship discord\n* (11) not having a family physician who we could contact if depression is diagnosed during the assessment\n* (12) difficulty in complying with questionnaires or in completing interview.'}, 'identificationModule': {'nctId': 'NCT01702818', 'acronym': 'MODEST', 'briefTitle': "Stress Hormones, Mood and Women's Sexual Desire (MODEST)", 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': "Stress Hormones, Mood and Women's Sexual Desire (MODEST)", 'orgStudyIdInfo': {'id': 'H10-02067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HSDD group', 'description': 'Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).'}, {'label': 'Control Group', 'description': 'Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Centre for Sexual Medicine', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Rosemary Basson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Lori A Brotto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lori Brotto', 'investigatorAffiliation': 'University of British Columbia'}}}}