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Local Anesthetic
Pelvic Rehabilitation for Dyspareunia
Phase 4
Waitlist Available
Led By Mary South, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 10
Awards & highlights
Approved for 20 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Summary
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
Eligible Conditions
- Dyspareunia
- Painful Intercourse
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale
Secondary study objectives
Change in sexual function between visit 1 and visit 10
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Pelvic RehabilitationActive Control1 Intervention
Pelvic Rehabilitation will be conduction on weekly basis for a total of 6 weeks
Group II: Trigger Point InjectionsActive Control1 Intervention
Trigger point injections will be administered on weekly basis for a total of 6 weeks
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Who is running the clinical trial?
Patty Brisben Foundation For Women's Sexual HealthOTHER
6 Previous Clinical Trials
359 Total Patients Enrolled
1 Trials studying Dyspareunia
40 Patients Enrolled for Dyspareunia
University of CincinnatiLead Sponsor
435 Previous Clinical Trials
635,302 Total Patients Enrolled
1 Trials studying Dyspareunia
70 Patients Enrolled for Dyspareunia
Mary South, MDPrincipal InvestigatorUniversity of Cincinnati
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