Status:
UNKNOWN
The Effect of Selective Oxytocin Receptor Inhibitors on Endometriosis-related Pain
Lead Sponsor:
Radboud University Medical Center
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 intrav...
Detailed Description
Rationale: Endometriosis is a common chronic, incurable condition in which endometrium-like tissue implants outside the uterus. In the Netherlands approximately 405,000 women between 15 and 50 years o...
Eligibility Criteria
Inclusion
- Laparoscopic, MRI or ultrasound confirmed endometriosis
- Dysmenorrhea with an average pain score ≥5 on the most painful day during menstrual period or withdrawal bleeding
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05382143
Start Date
February 1 2022
End Date
July 1 2022
Last Update
May 19 2022
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands