The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: Ibuprofen

• Registration Number: NCT02580344
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-18
• Study First Submitted QC: 2015-10-18
• Study First Posted: 2015-10-20
• Primary Completion: 2016-09
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Number of bleeding days per month	3 months	by menstrual diary

Secondary Outcome Measures

Name	Time	Method
Uterine Doppler indices	3 months

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt