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

This study has been completed.
Sponsor:
Collaborator:
Merck Quimica Argentina S.A.I.C
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080053
First received: March 2, 2010
Last updated: October 13, 2013
Last verified: October 2013
  Purpose

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
Multiple Sclerosis, Relapsing Remitting

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Mini-Mental State Examination (MMSE) Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ) Hamilton Rating Scale for Depression (HRSD)


Enrollment: 306
Study Start Date: November 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with established diagnosis of RRSM for more than one year.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080053

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

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080053     History of Changes
Other Study ID Numbers: EMR200077-511
Study First Received: March 2, 2010
Last Updated: October 13, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

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

ClinicalTrials.gov processed this record on October 21, 2014