ContraceptionPhase 4PAP-AIDNCT05890495
Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
A Phase 4 study testing Lidocaine topical and Tampon in people with Contraception, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Lidocaine topical and Tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2023to Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Request IUD insertion
- Age 18 or older
- Willingness to return for procedure after completing virtual study consent
Who cannot join
- Known allergy to viscous lidocaine or tampons
- Current vaginal or cervical injury
Trial locations and contacts
1 site in 1 country.
United States1 site
University Family Health Center, USUHS
Bethesda, Maryland, 20814
Michael J Arnold, MD, 301-295-9853, michael.arnold@usuhs.edu
About this study
The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are:
- Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration?
- Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.
Read the detailed description
This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure.
The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.
- Conditions
- Contraception
- Being tested
- Lidocaine topical, Tampon
- Keywords
- Long-Acting Reversible Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine topicalDrug
Also called Lidocaine hydrochloride topical solution, USP, 4%
4% aqueous solution
TamponDevice
Tampon with plastic applicator provided
| Study group | Role | What they receive |
|---|---|---|
| Aqueous lidocaine | Experimental | Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement. Receives: Drug: Lidocaine topical; Device: Tampon |
| Saline | Placebo comparator | Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement. Receives: Device: Tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD)
Measured: Measured during procedure
Patient-reported pain level
0-10 Visual analog scale
Measured: Obtained immediately after the procedure prior to the patient leaving the clinic
Secondary outcomes (3)
Patient-reported satisfaction with procedure
0 - 100%
Measured: Obtained immediately after the procedure prior to the patient leaving the clinic
Patient-reported interest in subsequent procedure
Likert scale
Measured: Obtained immediately after the procedure prior to the patient leaving the clinic
Provider-reported procedural difficulty
Likert scale
Measured: Obtained immediately after the procedure prior to the patient leaving the clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- American Academy of Family Physicians National Research Network
- Responsible party
- Principal investigator, Mike Arnold, Uniformed Services University of the Health Sciences
- Investigators
- Michael J Arnold, MD, Principal investigator, Associate Professor, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890495
- Sponsor's protocol ID
- USUHS.2022-103
- Acronym
- PAP-AID
- Status last verified
- May 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement
- ClinicalTrials.gov ID
- NCT05890495
- Acronym / sponsor ID
- PAP-AID / USUHS.2022-103
- Conditions
- Contraception
- Keywords
- Long-Acting Reversible Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- American Academy of Family Physicians National Research Network
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to perform a pilot study looking at the benefit of topical anesthetic application to the cervix by tampon prior to intra-uterine device insertion. The main question it aims to answer are:
- Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce procedural duration?
- Does patient tampon-applied local anesthetic prior to insertion of an intrauterine device (IUD) reduce pain and improve patient perceptions of the procedure? Participants will place a tampon after dipping the tampon into the study-supplied medication (aqueous lidocaine or saline). Researchers will compare treatment and control groups to see if there is any difference in procedure time, difficulty or patient perceptions.
Detailed description
This Pilot Randomized Double Blind Clinical Trial study will assess the effectiveness of patient-applied aqueous lidocaine via tampon as a pre-treatment prior to intra-uterine device placement. Subjects will apply the lidocaine or a saline placebo to the end of a standard tampon with a plastic applicator and then place the tampon 1 hour prior to the procedure. The tampon will be removed as the subject prepares for the procedure.
The procedure team will measure the procedure time as well as the subject and provider impressions of the procedure. This data will be evaluated to compare the lidocaine to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aqueous lidocaine | Experimental | Drug: Lidocaine topical, Device: TamponSubject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement. |
| Saline | Placebo comparator | Device: TamponSubject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Request IUD insertion
- Age 18 or older
- Willingness to return for procedure after completing virtual study consent
Key exclusion criteria (2 listed)
- Known allergy to viscous lidocaine or tampons
- Current vaginal or cervical injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine topicalAlso: Lidocaine hydrochloride topical solution, USP, 4%4% aqueous solution | Drug | Aqueous lidocaine |
| TamponTampon with plastic applicator provided | Device | Aqueous lidocaine, Saline |
Primary outcome
Procedure time
Time frame: Measured during procedure
Time from uterine sounding to cutting strings (to allow for procedures where an IUD is removed prior to placing a new IUD)
Patient-reported pain level
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
0-10 Visual analog scale
3 secondary outcomes
Patient-reported satisfaction with procedure
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
Patient-reported interest in subsequent procedure
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
Provider-reported procedural difficulty
Time frame: Obtained immediately after the procedure prior to the patient leaving the clinic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Arnold, MD principal investigator
Associate Professor, Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine topical and Tampon in people with Contraception, run by Uniformed Services University of the Health Sciences 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 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Arnold, MD (301-295-9853, michael.arnold@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: Measured during 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?
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 6 Jun 2023.