AzTrials
AzTrials

Pelvic PainMIPINCT03868137

Multi-dose Ibuprofen Prophylaxis for IUD-insertion

A study testing Ibuprofen in people with Pelvic Pain and IUD, run by Orlando VA Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pelvic Pain, IUD
What is being tested?
Ibuprofen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteUnited States
Study dates
28 Sep 2020to May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Chensi Ouyang, MD contact

407-631-1000

chensi.ouyang@va.gov

United States1 site, 1 recruiting

  • Orlando VA Medical Center

    Orlando, Florida, 32827

    Chensi Ouyang, MD, chensi.ouyang@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI): A Triple Blinded

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.

Read the detailed 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.

Conditions
Pelvic Pain, IUD
Being tested
Ibuprofen, Placebos
Keywords
NSAID, Intrauterine Devices, Ibuprofen, Pelvic pain
Medical subject headings
Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbuprofenDrug

    3 doses of Ibuprofen 800 mg

  • PlacebosDrug

    Placebo

Study groups in NCT03868137
Study groupRoleWhat they receive
PlaceboPlacebo comparator3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion
Receives: Drug: Placebos
IbuprofenExperimental3 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.
Receives: Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At time of IUD insertion

Secondary outcomes (2)

  1. Pain at 1 day after IUD insertion

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

    Measured: 1 day after IUD insertion

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

    Names of other medications or methods

    Measured: 1 day after IUD insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2019
  2. Study start28 Sep 2020
  3. Primary completionMay 2022 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03868137
Sponsor's protocol ID
1335793-1
Acronym
MIPI
Status last verified
Oct 2020
First submitted
6 Mar 2019
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26444110

  • 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.

    PubMed 16824298

  • 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.

    PubMed 16484309

  • 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.

    PubMed 9846090

  • 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.

    PubMed 22176793

  • 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.

    PubMed 25487172

  • 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.

    PubMed 4612152

  • 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.

    PubMed 26241253

  • 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.

    PubMed 27824753

  • 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.

    PubMed 21477680

  • 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.

    PubMed 25924648

Questions about this trial

What is this clinical trial studying?

A study testing Ibuprofen in people with Pelvic Pain and IUD, run by Orlando VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chensi Ouyang, MD (407-631-1000, chensi.ouyang@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain at time of IUD insertion (time frame: At time of IUD insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03868137, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in