The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding

Contraception Clinical Trial

Official title:

Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580344
• Other study ID #: IUD_Ibuprofen
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2015
• Last updated: March 20, 2017
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding days per month	by menstrual diary	3 months
Secondary	Uterine Doppler indices		3 months