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Effects of Spinal Cord Injury on Female Sexual Response

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ClinicalTrials.gov Identifier: NCT00142714
Recruitment Status : Unknown
Verified October 2006 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
First Posted : September 2, 2005
Last Update Posted : October 16, 2006
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description
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Brief Summary:
The long term aims of this project are to 1) Understand the effect of varying degrees and levels of SCI and dysfunction(SCI/D)on females sexual response: 2) Identify the specific neuronal pathways involved in female sexual responses; and 3) Develop and evaluate new assessment and treatment methods for neurogenic sexual dysfunction in women.

Condition or disease Intervention/treatment Phase
Female Sexual Dysfunction Multiple Sclerosis Spinal Cord Injury Procedure: Sympathetic manipulation on sexual arousal in women Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Effects of SCI on Female Sexual Response
Study Start Date : August 2003
Study Completion Date : June 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Our central hypothesis are:
  2. 1) In females the SNS regulates psychogenic genital vasocongestion 2) In females the orgasmic reflex requires the presence of an intact sacral spinal cord, 3) In females a pattern generator is responsible for the orgasmic reflex.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MS or SCI
  • Normal menstrual periods
  • Normal hand function
  • Have ability to feel sensation from lower abdomen to upper thigh region.

Exclusion Criteria:

  • Pregnant
  • Menopausal
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00142714


Contacts
Contact: Paula Spath 1-866-706-5544 pspath@uab.edu

Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Paula Spath    205-934-2088    pspath@uab.edu   
Principal Investigator: Marca Sipski, MD         
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Marca Sipski, MD The University of Alabama at Birmingham
More Information
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ClinicalTrials.gov Identifier: NCT00142714     History of Changes
Other Study ID Numbers: 5R01HD030149-09 ( U.S. NIH Grant/Contract )
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: October 16, 2006
Last Verified: October 2006

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
sexual response
sexual dysfunction in females
spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Multiple Sclerosis
Spinal Cord Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System