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

NCT01080053 | Completed

• 1 other identifier: EMR200077-511
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing Remitting

Keywords

Multiple Sclerosis, Relapsing Remitting; Sexual dysfunction

Outcome Measures

Primary Outcomes (1)

• 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)

  Initial visit (Day 0) and each follow up visit upto the observation period of 24 months

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Quimica Argentina S.A.I.C: collaborator

Study Sites (1)

Dr. Norma Deri

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Norma Deri, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: November 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

AR (1)