Sexual Dysfunction, Disability and Quality of Life in Patients With Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01080053
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : October 16, 2013
Merck Quimica Argentina S.A.I.C
Information provided by (Responsible Party):
Merck KGaA

Brief 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 dysfunction and the quality of life (QoL) of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina.

Condition or disease
Multiple Sclerosis, Relapsing Remitting

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 Type : Observational
Actual Enrollment : 306 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : November 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with established diagnosis of RRSM for more than one year.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01080053

Dr. Norma Deri
Buenos Aires, Argentina
Sponsors and Collaborators
Merck KGaA
Merck Quimica Argentina S.A.I.C
Principal Investigator: Norma Deri, PhD

Responsible Party: Merck KGaA Identifier: NCT01080053     History of Changes
Other Study ID Numbers: EMR200077-511
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Merck KGaA:
Multiple Sclerosis, Relapsing Remitting
Sexual dysfunction

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases