Hypoactive Sexual Desire DisorderNCT00569413
A Combined Psycho-pharmacological and Brain Imaging Study of Human Sexuality
An observational study of Hypoactive Sexual Desire Disorder and Erectile Dysfunction, run by Hadassah Medical Organization.
Trial summary
The current study combines a molecular genetic perspective, self report and brain imaging to the study of human sexuality in control subjects and individuals from a sexual disorder clinic. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder, Erectile Dysfunction
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2011
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A group of healthy volunteers from the general public. A group of patients who suffer from sexual disorder from a primary care clinic.
Who may be able to join
- Healthy volunteers and patients
- Age 21-65
- Male or female
Who cannot join
- Psychiatric diagnosis/psychosis
- Neurological damage associated with loss of consciousness
- Infectious disease HIV
- Herpes
- Syphilis
- Hyperactivity treated with ritalin
- Pregnant women
- Under age
About this study
The current study combines a molecular genetic perspective, self report and brain imaging to the study of human sexuality in control subjects and individuals from a sexual disorder clinic. The investigators hypothesize that the variability in components of the brain dopaminergic system expressed in the mesolimbic reward system can explain variability in human sexuality, especially in desire and pleasure associated with sex.
Read the detailed description
We intend to combine molecular genetics of the dopamine receptors (D2, D3 D4 and D5) and brain imaging using 11 C Raclopride in Positron Emission Tomography (PET). 11 C Raclopride is a ligand which binds to the dopamine receptor D2 and can measure dopamine release during pleasure or anticipatory reward associated with sex. The current proposal will measure changes in DRD2 receptor occupancy using 11 C Raclopride following explicit visual sexual desire cues in healthy control subjects and individuals who suffer from sexual dysfunction. This is in order to determine how individual genotypes modulate dopamine release in vivo in the human brain.
- Keywords
- Sex, brain imaging, dopamine, sexual disorder
- Medical subject headings
- Sexual Dysfunctions, Psychological, Erectile Dysfunction, Coitus, Sexual Dysfunction, Physiological
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 |
|---|---|---|
| 1 | Healthy control subjects (n=20) age 21-65 who do not suffer from a psychiatric diagnosis or neurological damage, are under age, or are pregnant women | |
| 2 | 20 patients who suffer from sexual disorder (reduced sexual desire or sexual function) from a sexual disorder clinic, age 21-65, without any other psychiatric disorder, neurological damage, are not under age or pregnant women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape
Measured: 2 Brain imaging sessions a week apart
Secondary outcomes (1)
Questionnaire ratings of human sexuality, pleasure, and anticipatory reward
Measured: Taken during brain scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startApr 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Investigators
- Aviv M Weinstein, Ph.D, Principal investigator, Hadasah Medical Organization, Jerusalem Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569413
- Sponsor's protocol ID
- 281207HMO-CTIL
- Other IDs
- First 978[1].07
- Status last verified
- Jun 2010
- First submitted
- 6 Dec 2007
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Psycho-pharmacological and Brain Imaging Study of Human Sexuality
- ClinicalTrials.gov ID
- NCT00569413
- Acronym / sponsor ID
- 281207HMO-CTIL
- Keywords
- Sex, brain imaging, dopamine, sexual disorder
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 7 Dec 2007 (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.
The current study combines a molecular genetic perspective, self report and brain imaging to the study of human sexuality in control subjects and individuals from a sexual disorder clinic. The investigators hypothesize that the variability in components of the brain dopaminergic system expressed in the mesolimbic reward system can explain variability in human sexuality, especially in desire and pleasure associated with sex.
Detailed description
We intend to combine molecular genetics of the dopamine receptors (D2, D3 D4 and D5) and brain imaging using 11 C Raclopride in Positron Emission Tomography (PET). 11 C Raclopride is a ligand which binds to the dopamine receptor D2 and can measure dopamine release during pleasure or anticipatory reward associated with sex. The current proposal will measure changes in DRD2 receptor occupancy using 11 C Raclopride following explicit visual sexual desire cues in healthy control subjects and individuals who suffer from sexual dysfunction. This is in order to determine how individual genotypes modulate dopamine release in vivo in the human brain.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Healthy control subjects (n=20) age 21-65 who do not suffer from a psychiatric diagnosis or neurological damage, are under age, or are pregnant women |
| 2 | – | –20 patients who suffer from sexual disorder (reduced sexual desire or sexual function) from a sexual disorder clinic, age 21-65, without any other psychiatric disorder, neurological damage, are not under age or pregnant women. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A group of healthy volunteers from the general public. A group of patients who suffer from sexual disorder from a primary care clinic.
Key inclusion criteria (3 listed)
- Healthy volunteers and patients
- Age 21-65
- Male or female
Key exclusion criteria (8 listed)
- Psychiatric diagnosis/psychosis
- Neurological damage associated with loss of consciousness
- Infectious disease HIV
- Herpes
- Syphilis
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
Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape
Time frame: 2 Brain imaging sessions a week apart
1 secondary outcome
Questionnaire ratings of human sexuality, pleasure, and anticipatory reward
Time frame: Taken during brain scans
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
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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.
Aviv M Weinstein, Ph.D principal investigator
Hadasah Medical Organization, Jerusalem Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoactive Sexual Desire Disorder and Erectile Dysfunction, run by Hadassah Medical Organization.
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 3 inclusion and 8 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: paused, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape (time frame: 2 Brain imaging sessions a week apart). 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 10 Jun 2010.