NCT03868137

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

March 6, 2019

Last Update Submit

October 7, 2020

Conditions

Pelvic PainIUD

Keywords

NSAIDIntrauterine DevicesIbuprofenPelvic pain

Outcome Measures

Primary Outcomes (1)

  • Pain at time of IUD insertion

    Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain

    At time of IUD insertion

Secondary Outcomes (2)

  • Pain at 1 day after IUD insertion

    1 day after IUD insertion

  • Usage of other medications or methods to decrease post-IUD insertion pain

    1 day after IUD insertion

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Ibuprofen

EXPERIMENTAL

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.

Drug: Ibuprofen

Interventions

IbuprofenDRUG

3 doses of Ibuprofen 800 mg

Ibuprofen
PlacebosDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatient must be female since IUDs are female contraception.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando VA Medical Center

Orlando, Florida, 32827, United States

RECRUITING

Related Publications (11)

  • 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.

    PMID: 26444110BACKGROUND

  • 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.

    PMID: 16824298BACKGROUND

  • 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.

    PMID: 16484309BACKGROUND

  • 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.

    PMID: 9846090BACKGROUND

  • 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.

    PMID: 22176793BACKGROUND

  • 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.

    PMID: 25487172BACKGROUND

  • 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.

    PMID: 4612152BACKGROUND

  • 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.

    PMID: 26241253BACKGROUND

  • 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.

    PMID: 27824753BACKGROUND

  • 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.

    PMID: 21477680RESULT

  • 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.

    PMID: 25924648RESULT

MeSH Terms

Conditions

Pelvic Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Chensi Ouyang, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A randomization sequence will be generated and given to the research pharmacist who will dispense the appropriate medications to the participants in each arm. Only the pharmacist will know which patient is in which trial arm until the study has ended and data has been analyzed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 8, 2019

Study Start

September 28, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)