Multiple Sclerosis, Relapsing RemittingNCT01080053
Sexual Dysfunction, Disability and Quality of Life in Patients With Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, Relapsing Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.
Trial summary
This is an observational, prospective, non-interventional, non-controlled study planned to be conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). The purpose of this observational study is to determine the correlation between the degree of disability and sexual dysfunction; and between the sexual… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing Remitting
- How many people
- 306 participants
- Where
- 1 siteArgentina
- Study dates
- Nov 2008to May 2013
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with established diagnosis of RRSM for more than one year.
Who may be able to join
- Men and women > 21 years of age
- Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- Subjects with a diagnosis of RRMS for more than one year
- The subject who have signed the Informed Consent
Who cannot join
- Subjects with no sexual experience
- Subjects with other diseases associated to MS
- Subjects with psychiatric diseases that could cause sexual dysfunction
- Subjects with one relapse during the previous month
- Use of antidepressants and/or corticosteroids during the previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Determine the Relationship Between the Degree of Disability and the Presence of Sexual Dysfunction and Between Sexual Dysfunction and the Quality of Life in Patients With Multiple Sclerosis (RRMS)
This is an observational, prospective, non-interventional, non-controlled study planned to be conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).
The purpose of this observational study is to determine the correlation between the degree of disability and sexual dysfunction; and between the sexual dysfunction and the quality of life (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.
Read the detailed description
Multiple sclerosis, like most of the chronic diseases, can affect the sexuality of those who suffer from it. This situation has an evident and marked impact on the QoL of the subjects and his/her partner, and causes conflict in the relationship, with high levels of mutual dissatisfaction.
The impact that the duration of the disease or the degree of disability have on the level of sexual dysfunction is not clear. However, the possible organic and state of mind causes of the sexual dysfunction makes us think that the degree of disability is a crucial factor in the genesis and duration of the symptoms in the sexual area. The frequency with which the sexual dysfunction is detected or referred in these subjects is variable.
The sexual dysfunction in subjects with MS is typically characterized by a decreased libido, erectile dysfunction and ejaculation disorders in men, and decreased lubrication and anorgasmia in women. The most commonly detected problems are the erectile dysfunction and/or lack of sexual interest in men and lack of interest, decreased libido and orgasmic disorder in women.
This observational study aims to assess a population of subjects with MS that show symptoms of sexual dysfunction, in order to determine the relationship, if any, between the severity of the general disability and the incidence of sexual dysfunction. At the same time, this epidemiologic study aims to measure the impact the sexual dysfunction generates in the quality of life of subjects with MS.
The data to be obtained could contribute to a better understanding of the relationship between the studied variables and, eventually, to alert the treating doctors about the incidence of these morbid associations.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Keywords
- Multiple Sclerosis, Relapsing Remitting, Sexual dysfunction
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction, Physiological
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between the degree of disability and sexual dysfunction, and between the sexual dysfunction and the QoL of subjects
Mini-Mental State Examination (MMSE) Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ) Hamilton Rating Scale for Depression (HRSD)
Measured: Initial visit (Day 0) and each follow up visit upto the observation period of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startNov 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing RemittingStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Quimica Argentina S.A.I.C
- Responsible party
- Sponsor
- Investigators
- Norma Deri, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080053
- Sponsor's protocol ID
- EMR200077-511
- Status last verified
- Oct 2013
- First submitted
- 2 Mar 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Determine the Relationship Between the Degree of Disability and the Presence of Sexual Dysfunction and Between Sexual Dysfunction and the Quality of Life in Patients With Multiple Sclerosis (RRMS)
- ClinicalTrials.gov ID
- NCT01080053
- Acronym / sponsor ID
- EMR200077-511
- Conditions
- Multiple Sclerosis, Relapsing Remitting
- Keywords
- Multiple Sclerosis, Relapsing Remitting, Sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Quimica Argentina S.A.I.C
- Study start
- Nov 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Mar 2010 (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.
This is an observational, prospective, non-interventional, non-controlled study planned to be conducted in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).
The purpose of this observational study is to determine the correlation between the degree of disability and sexual dysfunction; and between the sexual dysfunction and the quality of life (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.
Detailed description
Multiple sclerosis, like most of the chronic diseases, can affect the sexuality of those who suffer from it. This situation has an evident and marked impact on the QoL of the subjects and his/her partner, and causes conflict in the relationship, with high levels of mutual dissatisfaction.
The impact that the duration of the disease or the degree of disability have on the level of sexual dysfunction is not clear. However, the possible organic and state of mind causes of the sexual dysfunction makes us think that the degree of disability is a crucial factor in the genesis and duration of the symptoms in the sexual area. The frequency with which the sexual dysfunction is detected or referred in these subjects is variable.
The sexual dysfunction in subjects with MS is typically characterized by a decreased libido, erectile dysfunction and ejaculation disorders in men, and decreased lubrication and anorgasmia in women. The most commonly detected problems are the erectile dysfunction and/or lack of sexual interest in men and lack of interest, decreased libido and orgasmic disorder in women.
This observational study aims to assess a population of subjects with MS that show symptoms of sexual dysfunction, in order to determine the relationship, if any, between the severity of the general disability and the incidence of sexual dysfunction. At the same time, this epidemiologic study aims to measure the impact the sexual dysfunction generates in the quality of life of subjects with MS.
The data to be obtained could contribute to a better understanding of the relationship between the studied variables and, eventually, to alert the treating doctors about the incidence of these morbid associations.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with established diagnosis of RRSM for more than one year.
Key inclusion criteria (4 listed)
- Men and women > 21 years of age
- Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- Subjects with a diagnosis of RRMS for more than one year
- The subject who have signed the Informed Consent
Key exclusion criteria (5 listed)
- Subjects with no sexual experience
- Subjects with other diseases associated to MS
- Subjects with psychiatric diseases that could cause sexual dysfunction
- Subjects with one relapse during the previous month
- Use of antidepressants and/or corticosteroids during the previous month
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
The correlation between the degree of disability and sexual dysfunction, and between the sexual dysfunction and the QoL of subjects
Time frame: Initial visit (Day 0) and each follow up visit upto the observation period of 24 months
Mini-Mental State Examination (MMSE) Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ) Hamilton Rating Scale for Depression (HRSD)
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 16 Oct 2013.
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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.
Norma Deri, PhD principal investigator
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 Multiple Sclerosis, Relapsing Remitting, run by Merck KGaA, Darmstadt, Germany at 1 site in Argentina.
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 4 inclusion and 5 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 16 Oct 2013. 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 Argentina. 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?
The correlation between the degree of disability and sexual dysfunction, and between the sexual dysfunction and the QoL of subjects (time frame: Initial visit (Day 0) and each follow up visit upto the observation period of 24 months). 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 16 Oct 2013.