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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
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ibuprofen Drug: Ibuprofen
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days




Primary Outcome Measures :
  1. Number of bleeding days per month [ Time Frame: 3 months ]
    by menstrual diary


Secondary Outcome Measures :
  1. Uterine Doppler indices [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women have menorrhagia secondary to IUD.
  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:

  1. Evidence of defective coagulation.
  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

Information from the National Library of Medicine

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


Locations
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Egypt
Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02580344     History of Changes
Other Study ID Numbers: IUD_Ibuprofen
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ibuprofen
Hemorrhage
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action