Recruiting

Menstrual Disc & Cervical Cap

Sponsor:

Oregon Health and Science University

Code:

NCT06891794

Conditions

IUD

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Menstrual disc with EMLA cream

Cervical cap with EMLA cream

Study Details

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

Study ID

NCT06891794

Start date

Aug 4, 2025

Status verified date

Aug, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Menstrual disc

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.

experimental: Cervical cap

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.

Interventions

Menstrual disc with EMLA cream

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

Cervical cap with EMLA cream

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

Primary outcome measure

  • Successful Placement [ Time Frame: Immediately after IUD placement procedure ]
  • Satisfaction with pain control [ Time Frame: Immediately after IUD placement procedure ]

Central Contacts and Locations

Central contacts

Women's Health Research Unit Department of Ob/Gyn

503-494-3666whru@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Women's Health Research Unit

503-494-3666whru@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Keywords

  • Topical Anesthetic
  • IUD Insertion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-08-08.