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Dopamine Agonist
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain (RAQUEL Trial)
Phase 2
Waitlist Available
Research Sponsored by Ferring Pharmaceuticals
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 at baseline and at menstrual cycle 4 (around 4 months)
Summary
This trial is testing a vaginal ring that releases a medication called quinagolide to help reduce pain in women with moderate to severe endometriosis. The goal is to see if this treatment is effective.
Eligible Conditions
- Endometriosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and at menstrual cycle 4 (around 4 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and at menstrual cycle 4 (around 4 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)
Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)
Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase
+75 moreSide effects data
From 2022 Phase 2 trial • 22 Patients • NCT0369240333%
Corona virus infection
33%
Foot fracture
33%
Uterine disorder
33%
Major depression
100%
80%
60%
40%
20%
0%
Study treatment Arm
Quinagolide 720 µg - Part B
Quinagolide 1080 µg - Part B
Quinagolide 360 µg - Part A
Placebo - Part A
Quinagolide 720 µg - Part A
Quinagolide 360 µg - Part B
Quinagolide 1080 µg - Part A
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Quinagolide 720 µgExperimental Treatment1 Intervention
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Group II: Quinagolide 360 µgExperimental Treatment1 Intervention
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Group III: Quinagolide 1080 µgExperimental Treatment1 Intervention
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Group IV: PlaceboPlacebo Group1 Intervention
Vaginal ring containing matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quinagolide 360 µg
2018
Completed Phase 2
~30
Quinagolide 720 µg
2018
Completed Phase 2
~30
Quinagolide 1080 µg
2019
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Ferring PharmaceuticalsLead Sponsor
322 Previous Clinical Trials
1,242,229 Total Patients Enrolled
2 Trials studying Endometriosis
97 Patients Enrolled for Endometriosis
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
70 Previous Clinical Trials
1,158,546 Total Patients Enrolled
1 Trials studying Endometriosis
67 Patients Enrolled for Endometriosis