Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
No DNA Sample
Who is being recruted

Mental Disorders

+ Sexual Dysfunctions, Psychological

From 19 to 65 Years
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: February 2012
See protocol details

Summary

Principal SponsorUniversity of British Columbia
Last updated: October 17, 2018
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorUniversity of British Columbia
Last updated: October 17, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

324 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Mental DisordersSexual Dysfunctions, Psychological

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.
Treatment Groups
Study Objectives

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
CompletedOne Study Center