MODESTStress Hormones, Mood and Women's Sexual Desire (MODEST)
Data Collection
Collected at a single point in time - Cross-sectionalMental Disorders
+ Sexual Dysfunctions, Psychological
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: February 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.324 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 19 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
British Columbia Centre for Sexual Medicine
Vancouver, CanadaOpen British Columbia Centre for Sexual Medicine in Google Maps