Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968937
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-05-12
Brief Title:
Vaginal Baclofen Suppositories in Chronic Pelvic Pain
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Baclofen in Chronic Pelvic Pain a Randomized Double-Blind Placebo Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate if baclofen vaginal suppositories improve symptoms of Chronic Pelvic Pain CPP
Participants in this study will take four short questionnaires prior to being randomized Randomization is like flipping a coin participants have an equal likelihood of being randomized to the treatment group vaginal baclofen suppositories or placebo group vaginal suppository without baclofen ingredient Participants will take their assigned treatment nightly for 8 weeks Follow up visits will be at the 4 and 8 week time frames when questionnaires will again be completed Participants may receive additional treatments for CPP during the course of the study After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped Follow up on patient symptoms with questionnaires will again occur at 12 weeks
Participants in this study will take four short questionnaires prior to being randomized Randomization is like flipping a coin participants have an equal likelihood of being randomized to the treatment group vaginal baclofen suppositories or placebo group vaginal suppository without baclofen ingredient Participants will take their assigned treatment nightly for 8 weeks Follow up visits will be at the 4 and 8 week time frames when questionnaires will again be completed Participants may receive additional treatments for CPP during the course of the study After 8 weeks Participants will be offered a prescription for baclofen suppositories and the study drug will be stopped Follow up on patient symptoms with questionnaires will again occur at 12 weeks
Detailed Description:
Study DesignMethodology
This is a single center double-blinded placebo-controlled randomized trial Women will be recruited from a subspecialty clinic at the University of Louisville and be eligible for participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of 18-65 years old Eligible consenting participants will undergo randomization with equal probability of assignment to one of the two groups
1 Baclofen 20mg vaginal suppository daily per vagina and
2 placebo
Participants will be blinded to study allocation Baclofen or placebo suppositories will be continued to 8 weeks at which time all participants will be offered a baclofen suppository prescription Patients will then follow up at the 12 week mark and whether they continued baclofen suppositories and pill count will be recorded in addition to the below questionnaires
Clinical outcomes and questionnaires will be assessed at baseline and after 4 8 and 12 weeks of treatment Participants will be randomized with a stratified block randomization scheme with a random block size of 4 6 and 8 participants
Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic muscle dysfunction and perform pill count
We hypothesize a significant change in PROMIS Pain Interference score patient satisfaction PROMIS global health scores and PROMIS sexual function scores for patients assigned to the baclofen treatment arm
Inclusion Criteria
Women ages 18-65 years old
Women are not sexually active sexually active with same sex partners or are on effective contraception
Diagnosed with Chronic Pelvic Pain
Exclusion Criteria
Gross hematuria
Currently pregnant or breastfeeding
Unable to speak and read English
History of allergic reaction to baclofen tablet
History of allergic reaction to components of placebo coconut oil
History of gastrointestinal genitourinary or pelvic cancer in the last 5 years
This is a single center double-blinded placebo-controlled randomized trial Women will be recruited from a subspecialty clinic at the University of Louisville and be eligible for participation if they meet the diagnosis of Chronic Pelvic Pain and are between the ages of 18-65 years old Eligible consenting participants will undergo randomization with equal probability of assignment to one of the two groups
1 Baclofen 20mg vaginal suppository daily per vagina and
2 placebo
Participants will be blinded to study allocation Baclofen or placebo suppositories will be continued to 8 weeks at which time all participants will be offered a baclofen suppository prescription Patients will then follow up at the 12 week mark and whether they continued baclofen suppositories and pill count will be recorded in addition to the below questionnaires
Clinical outcomes and questionnaires will be assessed at baseline and after 4 8 and 12 weeks of treatment Participants will be randomized with a stratified block randomization scheme with a random block size of 4 6 and 8 participants
Participants will be required to come in for at least 1 visit at 8 weeks to assess pelvic muscle dysfunction and perform pill count
We hypothesize a significant change in PROMIS Pain Interference score patient satisfaction PROMIS global health scores and PROMIS sexual function scores for patients assigned to the baclofen treatment arm
Inclusion Criteria
Women ages 18-65 years old
Women are not sexually active sexually active with same sex partners or are on effective contraception
Diagnosed with Chronic Pelvic Pain
Exclusion Criteria
Gross hematuria
Currently pregnant or breastfeeding
Unable to speak and read English
History of allergic reaction to baclofen tablet
History of allergic reaction to components of placebo coconut oil
History of gastrointestinal genitourinary or pelvic cancer in the last 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None