Hypoactive Sexual Desire Disorder (HSDD)MODESTNCT01702818
Stress Hormones, Mood and Women's Sexual Desire (MODEST)
An observational study of Hypoactive Sexual Desire Disorder (HSDD), run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder (HSDD)
- How many people
- 324 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Who may be able to join
- (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.
Who cannot join
- (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
Show all 12Show fewer
- (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 locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Centre for Sexual Medicine
Vancouver, British Columbia, V6T 1Z9
About this study
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)
- Keywords
- Hypoactive Sexual Desire Disorder, HSDD, Cortisol, DHEA, Stress Hormones, Sexual Desire, Mood, Sexual Function, Childhood Maltreatment, Childhood Abuse
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HSDD group | Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD). | |
| Control Group | Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD). |
What is being measured
The primary outcome is the main question the study is designed to answer.
DHEA levels
DHEA levels derived from saliva samples.
Measured: Data is collected at 4 time points on 3 separate days
Secondary outcomes (8)
Cortisol levels
Cortisol levels derived from saliva samples.
Measured: Data is collected at 4 time points on 3 separate days
Depression
Depression will be measured by the Beck Depression Inventory (Beck \& Beamesderfer, 1974)
Measured: data is collected at single time point
Perceived stress
Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington \& Storch 2006)
Measured: data is collected at a single time point
Sexual function
Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))
Measured: data is collected at a single time point
Relationship satisfaction
Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)
Measured: data is collected at a single time point
History of childhood trauma
History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein \& Fink, 1995)
Measured: dat is collected at a single timepoint
History of childhood sexual abuse
History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)
Measured: data is collected at a single time point
PTSD symptoms
Presence and severity of post traumatic stress disorder symptoms will be determined through the Clinician-Administered PTSD Scale (Blake et al. 1998)
Measured: data is collected at a single time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire Disorder (HSDD)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Rosemary Basson, MD, Principal investigator, University of British ColumbiaLori A Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702818
- Sponsor's protocol ID
- H10-02067
- Acronym
- MODEST
- Status last verified
- May 2017
- First submitted
- 27 Aug 2012
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Hormones, Mood and Women's Sexual Desire (MODEST)
- ClinicalTrials.gov ID
- NCT01702818
- Acronym / sponsor ID
- MODEST / H10-02067
- Conditions
- Hypoactive Sexual Desire Disorder (HSDD)
- Keywords
- Hypoactive Sexual Desire Disorder, HSDD, Cortisol, DHEA, Stress Hormones, Sexual Desire, Mood, Sexual Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSDD group | – | –Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD). |
| Control Group | – | –Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (12 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DHEA levels
Time frame: Data is collected at 4 time points on 3 separate days
DHEA levels derived from saliva samples.
8 secondary outcomes
Cortisol levels
Time frame: Data is collected at 4 time points on 3 separate days
Depression
Time frame: data is collected at single time point
Perceived stress
Time frame: data is collected at a single time point
Sexual function
Time frame: data is collected at a single time point
Relationship satisfaction
Time frame: data is collected at a single time point
History of childhood trauma
Time frame: dat is collected at a single timepoint
History of childhood sexual abuse
Time frame: data is collected at a single time point
PTSD symptoms
Time frame: data is collected at a single time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- UBC Sexual Health LabLink provided by the sponsor.
Related trials for Hypoactive Sexual Desire Disorder (HSDD)
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary Basson, MD principal investigator
University of British Columbia
Lori A Brotto, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoactive Sexual Desire Disorder (HSDD), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DHEA levels (time frame: Data is collected at 4 time points on 3 separate days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.