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NCT Number: NCT06891794

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

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.

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Key information

Conditions

IUD

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Women's Health Research Unit

CONTACT

[email protected]

503-494-3666

About this study

Nulliparous patients undergoing IUD insertion will administer EMLA cream by menstrual disc or cervical cap prior to insertion. The medical provider will ensure proper placement of the cap or disc and perform a bi-manual exam to assess the patient's uterine position. A seven minute timer will be set, the cap/disc will be removed, and the provider will proceed with the IUD insertion according to manufacturer technique.

Visual Analog Scale (VAS) scores will be used throughout the procedure to assess participant pain throughout insertion. Participants and providers will report on pain, side effects, and procedure complications immediately after the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menstrual disc with EMLA cream

Combination Product

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

Other names: 2.5% prilocaine-2.5% lidocaine cream, Softdisc

Cervical cap with EMLA cream

Combination Product

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

Other names: FemCap, 2.5% prilocaine-2.5% lidocaine cream

Primary outcomes

  1. Successful Placement

    Time frame: Immediately after IUD placement procedure

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

  2. Satisfaction with pain control

    Time frame: Immediately after IUD placement procedure

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

Secondary outcomes

  1. Ease of cap/disc placement

    Time frame: Immediately after IUD placement procedure

    Participant-reported ease of placement of menstrual cap or disc. Response options will be "very easy", "somewhat easy", "neutral", "somewhat difficult", and "very difficult".

  2. Protocol deviations

    Time frame: Immediately after IUD placement procedure

    Provider-reported deviations from the standard protocol including need for additional analgesia, oral pain medication, oral anxiolytic medication, need for cervical dilation, rescheduling with sedation per patient preference, or other.

  3. Ease of IUD placement

    Time frame: Immediately after IUD placement procedure

    Provider-reported ease of IUD placement with response options "usual", "difficult", or "very difficult"

  4. Procedure complications

    Time frame: Immediately after IUD placement procedure

    Provider-reported complications of IUD placement procedure including vagal reaction, perforation, placement failure, allergic reaction, or other.

  5. Typical menstrual pain

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

    Patient-reported 11-point Numerical Rating Scale (NRS) of their menstrual pain where 0 represents no pain and 10 represents the worst possible pain.

  6. Pain during IUD placement procedure

    Time frame: Measured throughout IUD placement procedure immediately before the procedure, during placement of disc/cap, during speculum placement, during tenaculum placement, during sounding, during IUD placement, and 5 minutes after completion

    Patient-reported pain using a 100 millimeter Visual Analog Scale (VAS) throughout IUD placement procedure. Participants will mark their level of pain along a 100mm line, where one end (0) represents no pain and the other represents the worst possible pain (100). The distance from the "no pain" end to the participant's mark is measured to provide a numeric representation of pain

  7. Acceptability of pain mangement

    Time frame: one day post-procedure

    Patient-reported acceptability of pain management measured by a 5-point Likert scale question. Participants will be asked "How would you rate your satisfaction with the pain control during your IUD placement?". Response options range from very satisfied (1) to very dissatisfied (5).

Other outcomes

  1. Reasons for non-participation

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

    For eligible prospective participants who were approached but declined participation, they will be asked the reason why they chose not to participate. This will be an open-ended response where the study staff member performing the screening will record the reason for declining participation.

Study contacts

Contact information is provided by the study sponsor or research team.

Women's Health Research Unit Department of Ob/Gyn

CONTACT

[email protected]

503-494-3666

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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