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

NCT06891794 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-08

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Menstrual disc with EMLA cream

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

COMBINATION_PRODUCT

Cervical cap with EMLA cream

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

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Julia Tasset · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06891794 on ClinicalTrials.gov