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

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University of British Columbia

Status

Completed

Conditions

Hypoactive Sexual Desire Disorder (HSDD)

Study type

Observational

Funder types

Other

Identifiers

NCT01702818
H10-02067

Details and patient eligibility

About

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.

Enrollment

324 patients

Sex

Female

Ages

19 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

324 participants in 2 patient groups

HSDD group
Description:
Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Control Group
Description:
Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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