Topical Anesthetic for IUD Insertion Study

This study is looking at whether using a topical anesthetic (pain-numbing cream called EMLA cream) applied with either a menstrual disc or a cervical cap can help reduce pain during an IUD (intrauterine device) insertion. You might be able to join if you are a woman between 18 and 45 years old, are generally healthy, and are scheduled for an IUD placement at the Center for Women's Health. The study aims to see if these methods successfully place the IUD and if participants are satisfied with their pain control immediately after the procedure. This study is currently recruiting 24 participants.

Study design
This is an open-label study, meaning you and your doctor will know which treatment you receive. It will involve 24 participants, with 12 receiving EMLA cream via a menstrual disc and 12 via a cervical cap.
What's involved
You would self-administer the EMLA cream using a menstrual disc or cervical cap before your IUD insertion. Your pain levels will be assessed during and immediately after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your satisfaction with pain control and successful IUD placement will be measured immediately after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06891794

Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion

Recruiting
NAAges 18–45InterventionalPrevention
Oregon Health and Science University
~24 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:Menstrual disc with EMLA creamCervical cap with EMLA cream

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful Placement
Measured over Immediately after IUD placement procedure
+1 more outcome measured
IUD
1 sites across 1 states
Oregon1
  • Julia Tasset · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Women's Health Research Unit Department of Ob/Gyn
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Eligibility criteria

Inclusion

Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic
Able to review and sign study consents in English
Generally healthy

Exclusion

History of any prior births, miscarriages, or abortions after 16 weeks' gestation
Currently pregnant, known or suspected
Current stringless IUD in place
Participants premedicated with misoprostol
History of chronic pelvic pain which patients take daily medication for
History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)
Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)
Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap
Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap
Previous IUD placement or failed attempt of an IUD placement
Weight \< 54.4kg (120 lbs)
Plan for use of oral anxiolysis, moderate/deep sedation, or narcotics for procedure
Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate/deep sedation, or narcotics
Any planned concomitant procedures, such as dilation and curettage (D\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.
Illicit drug use
  • Successful PlacementImmediately after IUD placement procedure

    The number of participants able to correctly place the cap or disc as instructed, assessed by provider

  • Satisfaction with pain controlImmediately after IUD placement procedure

    Participant-reported satisfaction with pain control for IUD placement using EMLA cream measured the Patient Acceptable Symptom State (PASS) methodology.