The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
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|ClinicalTrials.gov Identifier: NCT02580344|
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : March 21, 2017
The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device.
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Ibuprofen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||November 2016|
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
- Number of bleeding days per month [ Time Frame: 3 months ]by menstrual diary
- Uterine Doppler indices [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580344
|Assiut, Egypt, 71111|