Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05382143 |
Other study ID # |
NL67501.091.18 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
February 1, 2022 |
Est. completion date |
July 1, 2022 |
Study information
Verified date |
April 2022 |
Source |
Radboud University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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 of age are estimated to have endometriosis in some degree. Symptoms may vary
through the menstrual cycle and include but are not limited to: dysmenorrhea (pain during
menstruation), chronic pelvic pain, dyspareunia (pain during or after sexual intercourse) and
dyschezia (pain during defecation). Current treatment options consist of analgesics, hormonal
treatment and more or less invasive surgery. Following histological findings and in vitro and
animal research, oxytocin receptor antagonists might be an alternative, non-hormonal,
non-invasive treatment option. Except for one study on advanced reproductive techniques, no
studies have reported the use of selective oxytocin receptor antagonists in human patients.
The investigators hypothesize atosiban, a selective oxytocin receptor antagonist that is
currently available in an intravenous administration form, can significantly lower patients'
pain scores. If this pilot study shows atosiban is an effective treatment option for women
with endometriosis, the investigators intend to develop a patient-friendly mode of
administration for atosiban.
Objective: To investigate the potential of atosiban as a treatment for pain caused by
endometriosis.
Study design: Phase II interventional pilot study Study population: 10 patients with
laparoscopic, MRI or ultrasound proven endometriosis Intervention (if applicable): Atosiban
6,75mg intravenously bolus, followed by 18mg per hour continuous infusion for 3 hours,
followed by 6mg per hour continuous infusion for 3 more hours.
Main study parameters/endpoints: Reduction in pain score (VAS), use of analgesics,
experienced side effects.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Participants will be admitted in day-care while they will receive intravenous
treatment with atosiban. They will be asked to keep a menstrual diary for one month, one time
before the treatment and another time afterwards. Furthermore, participants will be asked to
fill in questionnaires on quality of life and their medical history. Their pain scores will
be taken at several time points. The investigators will take blood samples at the start and
at the end of the treatment. The most important risk for participants is the risk of side
effects related to atosiban. These include nausea (>10%), headache, dizziness, flushes,
tachycardia, hypotension, vomiting, hypoglycaemia and local reaction on the place of
injection (1-10%). The most severe side effect described is pulmonary oedema. This was mostly
in combination with other tocolytic agents and very rare, the side effects are generally
considered to be mild. Atosiban has been administered on a routine basis to pregnant women
with preterm labour in the same regimen as is used now. However, the investigators will
administer atosiban for a shorter period of time. According to the risk classification of the
Netherlands Federation of University hospitals for patients participating in this study, the
risk has been assessed as "moderate".