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Atosiban as a potential treatment for endometriosis

Atosiban as a potential treatment for endometriosis - ENDOBAN pilot-study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47936
Enrollment
32
Registered
2019-04-30
Start date
2022-03-17
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrium outside of the uterus

Interventions

Atosiban 6,75 mg intravenously bolus, followed by 18 mg per hour continuous infusion for 3 hours, followed by 6 mg per hour continuous infusion for 3 more hours.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Laparoscopic, MRI or ultrasound confirmed endometriosis - Dysmenorrhea with painscore >=5 during menstrual period or withdrawal bleeding - Age between 18 and 45 years old

Exclusion criteria

Exclusion criteria: - 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 GnRh antagonist - 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

Design outcomes

Primary

MeasureTime frame
Reduction in pain score on a visual analog scale

Secondary

MeasureTime frame
Use of analgisics, experienced and observed side effects, oxytocin and prostaglandin serum levels before and after admission.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)