Multi-dose Ibuprofen Prophylaxis for IUD-insertion

Last updated: October 7, 2020
Sponsor: Orlando VA Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Intrauterine Device

Treatment

N/A

Clinical Study ID

NCT03868137
1335793-1
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

This study compares the effectiveness of decreasing pain at time of and day after intrauterine device (IUD) insertion when patients take three doses of Ibuprofen versus three doses of placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18

  • Female

  • Able to provide informed consent

  • English speaking

  • Able to provide telephone and address contact information

  • Able and willing to receive HIPAA compliant telephone texts and phone messages

  • Stable (the same) address and phone number within the last 6 months.

Exclusion

Exclusion Criteria:

  • Contraindications to IUD insertion (active pelvic infection, current pregnancy)

  • Contraindications to NSAIDs (allergy, history of asthma, history of aspirin allergy,history of kidney disease, history of stomach ulcer, history of active GI bleeding,history of liver disease)

  • Not undergoing any other concurrent office procedures

Study Design

Total Participants: 86
Study Start date:
September 28, 2020
Estimated Completion Date:
May 31, 2022

Study Description

Ibuprofen is commonly used over the counter and prescribed for pain relief such as menstrual cramps. Intrauterine (IUD) insertion can cause pain during and after the insertion. Currently, studies have found that single dose of Ibuprofen take prior to IUD insertion does decrease pain at time of IUD insertion. This study will examine whether 3 doses of Ibuprofen can decrease pain at time of and 1 day after IUD insertion.

Connect with a study center

  • Orlando VA Medical Center

    Orlando, Florida 32827
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.