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

NCT06891794 | Recruiting

• 1 other identifier: OHSU IRB 28118
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc. Twenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.

Conditions

IUD

Keywords

Topical Anesthetic; IUD Insertion

Outcome Measures

Primary Outcomes (2)

• Successful Placement

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

  Immediately after IUD placement procedure

• Satisfaction with pain control

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

  Immediately after IUD placement procedure

Secondary Outcomes (7)

• Ease of cap/disc placement

  Immediately after IUD placement procedure

• Protocol deviations

  Immediately after IUD placement procedure

• Ease of IUD placement

  Immediately after IUD placement procedure

• Procedure complications

  Immediately after IUD placement procedure

• Typical menstrual pain

  On the day of IUD placement procedure prior to cap/disc placement and IUD placement

Other Outcomes (1)

• Reasons for non-participation

  During screening/enrollment at the time when an eligible participant declines participation

Study Arms (2)

Menstrual disc

EXPERIMENTAL

Participants will be provided with a menstrual disc filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the disc. The provider will return to the room, make sure the disc is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the disc or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.

Combination Product: Menstrual disc with EMLA cream

Cervical cap

EXPERIMENTAL

Participants will be provided with a cervical cap filled with 5mg of 2.5% prilocaine-2.5% lidocaine cream and manufacturer instructions for placement. Study personnel will leave the room, and participants will undress and attempt to place the cap. The provider will return to the room, make sure the cap is correctly placed, and set a seven minute timer. After the seven minute timer, participants will self-remove the cap or the clinician will remove it and place the intrauterine device (IUD) according to manufacturer technique.

Combination Product: Cervical cap with EMLA cream

Interventions

Menstrual disc with EMLA cream COMBINATION_PRODUCT

Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc

Also known as: 2.5% prilocaine-2.5% lidocaine cream, Softdisc

Menstrual disc

Cervical cap with EMLA cream COMBINATION_PRODUCT

Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc

Also known as: FemCap, 2.5% prilocaine-2.5% lidocaine cream

Cervical cap

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination; Contraceptive Devices, Female

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Contraceptive Devices; Equipment and Supplies

Study Officials

• Julia Tasset

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study that involves no masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into one of two arms (menstrual disc or cervical cap) for eutectic mixture of local anesthetics (EMLA) cream application prior to intrauterine device (IUD) insertion

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 24, 2025
• Study Start: August 4, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)