Recruiting

Ibuprofen

Sponsor:

Orlando VA Medical Center

Code:

NCT03868137

Conditions

Pelvic Pain

IUD

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ibuprofen

Placebos

Study Details

Brief 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.

Conditions

Pelvic Pain

IUD

Study ID

NCT03868137

Start date

Sep 28, 2020

Status verified date

Oct, 2020

Completion date

May, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 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

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion

experimental: Ibuprofen

3 doses of Ibuprofen 800 mg will be given to patients starting 1 day before IUD insertion. Patient will take 800 mg Ibuprofen at noon and 8 PM day before IUD insertion and at 8 AM on the day of IUD insertion.

Interventions

Ibuprofen

3 doses of Ibuprofen 800 mg

Placebos

Placebo

Primary outcome measure

  • Pain at time of IUD insertion [ Time Frame: At time of IUD insertion ]

Central Contacts and Locations

Central contacts

Chensi Ouyang, MD

407-631-1000chensi.ouyang@va.gov

Locations

Orlando VA Medical Center

Recruiting

Orlando, Florida, United States, 32827

Contacts

Chensi Ouyang, MD

chensi.ouyang@va.gov

More Information

Sponsor

Orlando VA Medical Center

Last update posted

Oct 9, 2020

Last verified

Oct, 2020

Keywords

  • NSAID
  • Intrauterine Devices
  • Ibuprofen
  • Pelvic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando VA Medical Center on 2020-10-09.