The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
NCT ID: NCT02580344
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2015-10-31
2016-11-30
Brief Summary
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Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting.
Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen.
The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ibuprofen
Ibuprofen
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
Interventions
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Ibuprofen
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
Eligibility Criteria
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Inclusion Criteria
2. Planning for birth spacing for at least 1 year.
3. Patient aged between 20-45 years old.
4. No history of any medical treatment.
5. Living in a nearby area to make follow-up reasonably possible.
Exclusion Criteria
2. History or evidence of malignancy.
3. Hyperplasia in the endometrial biopsy.
4. Incidental adnexal abnormality on ultrasound.
5. Untreated abnormal cervical cytology
6. contraindications to ibuprofen
20 Years
45 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohammed Khairy Ali
Dr
Locations
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Assiut university
Asyut, Asyut Governorate, Egypt
Countries
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Other Identifiers
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IUD_Ibuprofen
Identifier Type: -
Identifier Source: org_study_id
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