Clinical trial NCT01702818: Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Official title: Stress Hormones, Mood and Women's Sexual Desire (MODEST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoactive Sexual Desire Disorder (HSDD)
Keywords: Hypoactive Sexual Desire Disorder
HSDD
Cortisol
DHEA
Stress Hormones
Sexual Desire
Mood
Sexual Function
Childhood Maltreatment
Childhood Abuse
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 324
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

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.


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.

Primary outcomes:
measure: DHEA levels
timeFrame: Data is collected at 4 time points on 3 separate days
Secondary outcomes:
measure: Cortisol levels
timeFrame: Data is collected at 4 time points on 3 separate days
measure: Depression
timeFrame: data is collected at single time point
measure: Perceived stress
timeFrame: data is collected at a single time point
measure: Sexual function
timeFrame: data is collected at a single time point
measure: Relationship satisfaction
timeFrame: data is collected at a single time point
measure: History of childhood trauma
timeFrame: dat is collected at a single timepoint
measure: History of childhood sexual abuse
timeFrame: data is collected at a single time point
measure: PTSD symptoms
timeFrame: data is collected at a single time point
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Centre for Sexual Medicine
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Rosemary Basson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Lori A Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: