The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding

NCT02580344 | Completed Phase 2

• 1 other identifier: IUD_Ibuprofen
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Number of bleeding days per month

  by menstrual diary

  3 months

Secondary Outcomes (1)

• Uterine Doppler indices

  3 months

Study Arms (1)

Ibuprofen

OTHER

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

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

Ibuprofen

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Asyut Governorate, 71111, Egypt

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)