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OpenTrials
Completed

NCT Number: NCT02580344

The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding

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.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Assiut university

Asyut, Asyut Governorate, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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

Primary outcomes

  1. Number of bleeding days per month

    Time frame: 3 months

    by menstrual diary

Secondary outcomes

  1. Uterine Doppler indices

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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