Status:
COMPLETED
The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment
Lead Sponsor:
Mount Sinai Hospital, Canada
Conditions:
Contraception
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. Howev...
Eligibility Criteria
Inclusion
- Any participant presenting for an IUD placement, either for contraception or treatment of abnormal uterine bleeding or to regulate menstrual periods
- All IUDs (copper, hormonal) eligible
- All parities of patients are eligible
Exclusion
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Confirmed pregnancy
- Any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial cystitis)
- Misoprostol administration within 24 hours of enrollment
- Known contraindications to IUD placement
- Contraindication to lidocaine
- IUD exchange
- Previous unsuccessful attempt for IUD by the same practitioner
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2024
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT06532162
Start Date
June 30 2022
End Date
August 16 2024
Last Update
January 27 2025
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1Z5