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IUDNCT06891794

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

A study testing Menstrual disc with EMLA cream and Cervical cap with EMLA cream in people with IUD, run by Oregon Health and Science University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
IUD
What is being tested?
Menstrual disc with EMLA cream and Cervical cap with EMLA cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
4 Aug 2025to Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Women's Health Research Unit Department of Ob/Gyn contact

503-494-3666

whru@ohsu.edu

United States1 site, 1 recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Women's Health Research Unit, 503-494-3666, whru@ohsu.edu

    Recruiting

Other trials in United States

About this study

Official title: Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (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.

Read the detailed description

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.

Conditions
IUD
Being tested
Menstrual disc with EMLA cream, Cervical cap with EMLA cream
Keywords
Topical Anesthetic, IUD Insertion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Menstrual disc with EMLA creamCombination product

    Also called 2.5% prilocaine-2.5% lidocaine cream, Softdisc

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

  • Cervical cap with EMLA creamCombination product

    Also called FemCap, 2.5% prilocaine-2.5% lidocaine cream

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

Study groups in NCT06891794
Study groupRoleWhat they receive
Menstrual discExperimentalParticipants 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.
Receives: Combination Product: Menstrual disc with EMLA cream
Cervical capExperimentalParticipants 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.
Receives: Combination Product: Cervical cap with EMLA cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful Placement

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

    Measured: Immediately after IUD placement procedure

  2. Satisfaction with pain control

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

    Measured: Immediately after IUD placement procedure

Secondary outcomes (7)

  1. Ease of cap/disc placement

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

    Measured: Immediately after IUD placement procedure

  2. Protocol deviations

    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.

    Measured: Immediately after IUD placement procedure

  3. Ease of IUD placement

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

    Measured: Immediately after IUD placement procedure

  4. Procedure complications

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

    Measured: Immediately after IUD placement procedure

  5. Typical menstrual pain

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

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

  6. Pain during IUD placement procedure

    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

    Measured: 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

  7. Acceptability of pain mangement

    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).

    Measured: one day post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start4 Aug 2025
  3. Primary completionApr 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891794
Sponsor's protocol ID
OHSU IRB 28118
Status last verified
Aug 2025
First submitted
6 Mar 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Menstrual disc with EMLA cream and Cervical cap with EMLA cream in people with IUD, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Placement (time frame: Immediately after IUD placement procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06891794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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