RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion

Quick Facts

Study Start:2025-08-04

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06891794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666

whru@ohsu.edu

Principal Investigator

Julia Tasset

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Julia Tasset, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-04

Study Completion Date2026-04

Study Record Updates