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

NCT ID: NCT01702818

Last Updated: 2018-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-11-30

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.

Conditions

Hypoactive Sexual Desire Disorder (HSDD)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HSDD group

Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

No interventions assigned to this group

Control Group

Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• (1) diagnosis of HSDD
• (2) over 19 years of age
• (3) sexual complaints of low desire of at least 12 months duration.

• (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

• (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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Lori Brotto

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosemary Basson, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Lori A Brotto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

British Columbia Centre for Sexual Medicine

Vancouver, British Columbia, Canada

Countries

Canada

Related Links

http://brottolab.med.ubc.ca/

UBC Sexual Health Lab

Other Identifiers

H10-02067

Identifier Type: -

Identifier Source: org_study_id