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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00142714
Other study ID # 5R01HD030149-09
Secondary ID
Status Recruiting
Phase N/A
First received September 1, 2005
Last updated October 13, 2006
Start date August 2003
Est. completion date June 2005

Study information

Verified date October 2006
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact Paula Spath
Phone 1-866-706-5544
Email pspath@uab.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Intervention

Procedure:
Sympathetic manipulation on sexual arousal in women


Locations

Country Name City State
United States The University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Our central hypothesis are:
Primary 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.
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