The Effect of Selective Oxytocin Receptor Inhibitors on Endometriosis-related Pain
ENDOBAN
1 other identifier
interventional
10
1 country
1
Brief Summary
A pilot study to investigate the potential role of atosiban, a selective oxytocin receptor inhibitor, in the management of endometriosis-related pain. Ten patients will be administered atosiban intravenously during 6 hours on a day during their period when they experience (severe) pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 13, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMay 19, 2022
April 1, 2022
4 months
April 13, 2022
May 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in pain during and after the administration of atosiban
Pain scores on a visual analogue scale from 0 to 10, where higher scores mean more pain, during treatment and the month following treatment
Change from baseline up to 4 weeks
Secondary Outcomes (3)
Side effects of atosiban
Up to 4 weeks
Levels of serum prostaglandins
Baseline and directly after the administration of 6 hours atosiban
Side effect of atosiban
Baseline and directly after the administration of 6 hours atosiban
Study Arms (1)
Intervention
EXPERIMENTALAll the participants in this pilot study will receive atosiban
Interventions
Eligibility Criteria
You may qualify if:
- Laparoscopic, MRI or ultrasound confirmed endometriosis
- Dysmenorrhea with an average pain score ≥5 on the most painful day during menstrual period or withdrawal bleeding
You may not qualify if:
- Inability to come to the hospital for the experiment
- Suspicion on a (post)menopausal state
- Continuous treatment with oral contraceptives or progestagens
- Current use of gonadotrophin releasing-hormone agonist
- Current ovarian stimulation
- Current breastfeeding
- Labour or breastfeeding within the last 6 weeks
- Diagnosis of chronic pelvic pain
- Inability to give informed consent
- Language barrier
- Diabetes Mellitus, type I or II
- Hypersensitivity to atosiban or mannitol
- Use of systemic betamimetics
- Use of calcium channel blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Medical Center
Nijmegen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2022
First Posted
May 19, 2022
Study Start
February 1, 2022
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
May 19, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share