Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
86 participants
INTERVENTIONAL
2020-09-28
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion
Placebos
Placebo
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.
Ibuprofen
3 doses of Ibuprofen 800 mg
Interventions
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Ibuprofen
3 doses of Ibuprofen 800 mg
Placebos
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
Yes
Sponsors
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Orlando VA Medical Center
FED
Responsible Party
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Chensi Ouyang
Physician
Locations
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Orlando VA Medical Center
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Kavanaugh ML, Jerman J, Finer LB. Changes in Use of Long-Acting Reversible Contraceptive Methods Among U.S. Women, 2009-2012. Obstet Gynecol. 2015 Nov;126(5):917-927. doi: 10.1097/AOG.0000000000001094.
Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170.
Hubacher D, Reyes V, Lillo S, Pierre-Louis B, Zepeda A, Chen PL, Croxatto H. Preventing copper intrauterine device removals due to side effects among first-time users: randomized trial to study the effect of prophylactic ibuprofen. Hum Reprod. 2006 Jun;21(6):1467-72. doi: 10.1093/humrep/del029. Epub 2006 Feb 16.
Jensen HH, Blaabjerg J, Lyndrup J. [Prophylactic use of prostaglandin synthesis inhibitors in connection with IUD insertion]. Ugeskr Laeger. 1998 Nov 23;160(48):6958-61. Danish.
Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012 Jun;85(6):558-62. doi: 10.1016/j.contraception.2011.10.015. Epub 2011 Dec 15.
Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015 Mar;91(3):193-7. doi: 10.1016/j.contraception.2014.11.012. Epub 2014 Nov 25.
Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available.
Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912.
Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746.
Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12.
Lethaby A, Hussain M, Rishworth JR, Rees MC. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015 Apr 30;(4):CD002126. doi: 10.1002/14651858.CD002126.pub3.
Other Identifiers
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1335793-1
Identifier Type: -
Identifier Source: org_study_id
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