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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Contraception

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

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

First Posted
October 18, 2015
Last Updated
March 20, 2017
Sponsor
Assiut University
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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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