Female Sexual DysfunctionNCT00142714
Effects of Spinal Cord Injury on Female Sexual Response
A study testing Sympathetic manipulation on sexual arousal in women in people with Female Sexual Dysfunction and Multiple Sclerosis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Female Sexual Dysfunction, Multiple Sclerosis, Spinal Cord Injury
- What is being tested?
- Sympathetic manipulation on sexual arousal in women
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- MS or SCI
- Normal menstrual periods
- Normal hand function
- Have ability to feel sensation from lower abdomen to upper thigh region.
Who cannot join
- Pregnant
- Menopausal
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Paula Spath, 205-934-2088, pspath@uab.edu
Marca Sipski, MD
About this study
Official title: Effects of SCI on Female Sexual Response
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.
- Being tested
- Sympathetic manipulation on sexual arousal in women
- Keywords
- sexual response, sexual dysfunction in females, spinal cord injury
- Medical subject headings
- Multiple Sclerosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympathetic manipulation on sexual arousal in womenProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Our central hypothesis are:
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startAug 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Marca Sipski, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142714
- Sponsor's protocol ID
- 5R01HD030149-09
- Status last verified
- Oct 2006
- First submitted
- 1 Sep 2005
- Last updated
- 16 Oct 2006
- Results posted
- No
Publications
Alexander M, Bashir K, Alexander C, Marson L, Rosen R. Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. Arch Phys Med Rehabil. 2018 Feb;99(2):299-305. doi: 10.1016/j.apmr.2017.09.001. Epub 2017 Sep 9.
PubMed 28899827
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SCI on Female Sexual Response
- ClinicalTrials.gov ID
- NCT00142714
- Acronym / sponsor ID
- 5R01HD030149-09
- Keywords
- sexual response, sexual dysfunction in females, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Aug 2003
- Study completion
- Jun 2005
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- MS or SCI
- Normal menstrual periods
- Normal hand function
- Have ability to feel sensation from lower abdomen to upper thigh region.
Key exclusion criteria (2 listed)
- Pregnant
- Menopausal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sympathetic manipulation on sexual arousal in women | Procedure or surgery | – |
Primary outcome
Our central hypothesis are:
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2006.
- Derived from this study: PubMed 28899827Alexander M, Bashir K, Alexander C, Marson L, Rosen R. Randomized Trial of Clitoral Vacuum Suction Versus Vibratory Stimulation in Neurogenic Female Orgasmic Dysfunction. Arch Phys Med Rehabil. 2018 Feb;99(2):299-305. doi: 10.1016/j.apmr.2017.09.001. Epub 2017 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marca Sipski, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sympathetic manipulation on sexual arousal in women in people with Female Sexual Dysfunction and Multiple Sclerosis, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Spath (1-866-706-5544, pspath@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our central hypothesis are:. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2006.