Using a cervical cap or menstrual disc to apply numbing cream before IUD placement
Official title: Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion
Run by Oregon Health and Science University · NCT06891794 · Data updated 2026-11-12
This will test whether women getting an IUD can reduce insertion pain by self-applying numbing cream with either a menstrual disc or a cervical cap right before placement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | August 4, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT06891794 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Nulliparous women scheduled for office IUD placement at the Center for Women's Health who can consent in English and are otherwise healthy are ideal candidates.
✕Probably not a fit
People with prior births, current pregnancy, contraindications to IUD placement, or known allergies to EMLA or device materials are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, two-arm feasibility study will enroll 24 nulliparous women planning office IUD placement without sedation at Oregon Health & Science University. Participants will self-administer 5 g of EMLA cream delivered either in a menstrual disc or a cervical cap, with the provider confirming placement and starting a seven-minute dwell time before removal and standard IUD insertion. Pain will be recorded using visual analog scale (VAS) scores at specified steps during the procedure, and participants and providers will report side effects and complications immediately afterward. The trial is designed to compare tolerability and procedural pain between the two application methods and to determine feasibility for larger studies.
Why it matters
Potential benefit: If successful, this approach could reduce pain during IUD insertion for some patients by providing targeted topical anesthesia before the procedure.
How similar studies have gone: Topical anesthetics have shown mixed but sometimes positive effects for gynecologic procedures, while using a menstrual disc or cervical cap specifically for IUD anesthesia is a novel, feasibility approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Oregon Health & Science University
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Julia Tasset — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Department of Ob/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Carevix device vs. tenaculum for IUD insertion
This study tests whether using the Carevix suction cervical stabilizer during IUD insertion reduces patient-reported pain compared with the standard tenaculum.
-
Using TENS units to reduce pain during IUD insertion
This study is testing if using TENS units can help reduce pain for women aged 12 to 50 during IUD insertion.
-
Examining how menstrual cups may affect IUD displacement
This study is testing if using menstrual cups can cause IUDs to move out of place in women who use both.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.