The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
Primary Purpose
Contraception
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by

About this trial
This is an interventional treatment trial for Contraception
Eligibility Criteria
Inclusion Criteria:
- Women have menorrhagia secondary to IUD.
- Planning for birth spacing for at least 1 year.
- Patient aged between 20-45 years old.
- No history of any medical treatment.
- Living in a nearby area to make follow-up reasonably possible.
Exclusion Criteria:
- Evidence of defective coagulation.
- History or evidence of malignancy.
- Hyperplasia in the endometrial biopsy.
- Incidental adnexal abnormality on ultrasound.
- Untreated abnormal cervical cytology
- contraindications to ibuprofen
Sites / Locations
- Assiut university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ibuprofen
Arm Description
Outcomes
Primary Outcome Measures
Number of bleeding days per month
by menstrual diary
Secondary Outcome Measures
Uterine Doppler indices
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02580344
Brief Title
The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
Official Title
Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
Primary Outcome Measure Information:
Title
Number of bleeding days per month
Description
by menstrual diary
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Uterine Doppler indices
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women have menorrhagia secondary to IUD.
Planning for birth spacing for at least 1 year.
Patient aged between 20-45 years old.
No history of any medical treatment.
Living in a nearby area to make follow-up reasonably possible.
Exclusion Criteria:
Evidence of defective coagulation.
History or evidence of malignancy.
Hyperplasia in the endometrial biopsy.
Incidental adnexal abnormality on ultrasound.
Untreated abnormal cervical cytology
contraindications to ibuprofen
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
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