PainPhase 2NCT06496854
Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
A Phase 2 study testing Lorazepam 1 mg and Ibuprofen 800 mg in people with Pain and IUD, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Lorazepam 1 mg and Ibuprofen 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Jan 2026
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who undergo IUD insertion and complete the visual analogue scales to rate their anxiety and pain level prior to the procedure and after the procedure.
- Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
- Participants must have a driver take them home after the procedure as well.
- Participants must consent to email communication since they will sign the consent forms electronically
Who cannot join
- Participants who do not show up for their appointment.
- Participants who receive cervical blocks or other analgesic method during IUD insertion.
- Participants who have a history of substance use disorder.
- Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
- Participants who are not able to sign an electronic consent form.
- Participants who do not have a driver to take them to their appointment and to take them home after the procedure.
- Participants who do not agree to sign consent forms electronically.
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Family Medicine Residency Clinics
Madison, Wisconsin, 53715
About this study
The objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.
Read the detailed description
The purpose of the research is to evaluate the feasibility of prescribing lorazepam and measuring its effect on anxiety and pain with IUD insertion. The descriptive data from this study will be used to offer guidance for how to implement a larger scale study in the future.
Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure.
Secondary endpoints
- Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants.
- Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales
- Discuss participant's experiences with taking lorazepam and participating in the study
- Assess investigator's experience with the trial via a focus group
- Being tested
- Lorazepam 1 mg, Ibuprofen 800 mg
- Keywords
- IUD insertion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorazepam 1 mgDrug
1 mg oral lorazepam, a sedative used to relieve anxiety
Ibuprofen 800 mgDrug
800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain
| Study group | Role | What they receive |
|---|---|---|
| Lorazepam administration prior to IUD insertion procedure | Experimental | Not described Receives: Drug: Lorazepam 1 mg; Drug: Ibuprofen 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for Pain
Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain).
Measured: before and after the procedure (up to 1 hour)
Visual Analogue Scale for Anxiety
Participant will be asked to rate their anxiety on a scale of 0 (no anxiety) to 10 (severe anxiety).
Measured: before and after the procedure (up to 1 hour)
Secondary outcomes (6)
Mean Pain Scores for Nulliparous and Multiparous Participants
Comparison of mean pain scores between participants that have never had childbirth to those who have.
Measured: before and after the procedure (up to 1 hour)
Mean Anxiety Scores for Nulliparous and Multiparous Participants
Comparison of mean anxiety scores between participants that have never had childbirth to those who have.
Measured: before and after the procedure (up to 1 hour)
Number of Participants Recruited
Feasibility will in part be measured with recruitment rates.
Measured: up to 2 months (estimated time period of recruitment)
Number of Participants with lorazepam prescription adherence
Feasibility will in part be measured with adherence rates.
Measured: up to 2 months (estimated time period of recruitment)
Number of Participants Who Completed All Surveys
Feasibility will in part be measured with survey completion rates.
Measured: up to 2 months (estimated time period of recruitment)
Qualitative Measure: Participant Experience
Participants will be asked questions about their experience taking lorazepam and to provide feedback about the study. Participant answers will be coded and themed to report as participant counts.
Measured: post-procedure (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study startOct 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Unable to coordinate logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jensena Carlson, MD, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496854
- Sponsor's protocol ID
- 2024-0655
- Other IDs
- A532014, Protocol Version 6/5/2024
- Status last verified
- Oct 2025
- First submitted
- 3 Jul 2024
- Last updated
- 30 Oct 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06496854
- Acronym / sponsor ID
- 2024-0655
- Keywords
- IUD insertion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to coordinate logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 11 Jul 2024 (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 objective of this pilot study is to discuss the feasibility of prescribing lorazepam prior to IUD insertion and of measuring effect of lorazepam on anxiety and pain with Intrauterine Device (IUD) insertion. The target population for this study will be 25 adult participants scheduled for an IUD insertion at a UW Family Medicine residency clinic. Participants will be followed for 1 appointment visit.
Detailed description
The purpose of the research is to evaluate the feasibility of prescribing lorazepam and measuring its effect on anxiety and pain with IUD insertion. The descriptive data from this study will be used to offer guidance for how to implement a larger scale study in the future.
Primary endpoint: Assess preliminary differences in pain and anxiety scores pre-IUD insertion and post-IUD insertion using a Mann-Whitney U test. Participants will score their anxiety and pain levels pre-procedure and post-procedure using a 10cm visual analogue scale. This will be a one arm trial where all subjects will receive 1mg lorazepam and 800mg ibuprofen prior to the procedure.
Secondary endpoints
- Discuss if there was a difference in pain and anxiety scores among nulliparous (no previous childbirths) and multiparous (one or more previous childbirths) participants.
- Summarize recruitment rates, adherence to lorazepam prescription, completion rates of questionnaires and scales
- Discuss participant's experiences with taking lorazepam and participating in the study
- Assess investigator's experience with the trial via a focus group
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorazepam administration prior to IUD insertion procedure | Experimental | Drug: Lorazepam 1 mg, Drug: Ibuprofen 800 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who undergo IUD insertion and complete the visual analogue scales to rate their anxiety and pain level prior to the procedure and after the procedure.
- Participants must have a driver take them to their appointment if they take lorazepam prior to their arrival at the clinic.
- Participants must have a driver take them home after the procedure as well.
- Participants must consent to email communication since they will sign the consent forms electronically
Key exclusion criteria (7 listed)
- Participants who do not show up for their appointment.
- Participants who receive cervical blocks or other analgesic method during IUD insertion.
- Participants who have a history of substance use disorder.
- Participants who are taking medications with a central nervous system (CNS) depressant effect (ex: opioids, benzodiazepines).
- Participants who are not able to sign an electronic consent form.
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 |
|---|---|---|
| Lorazepam 1 mg1 mg oral lorazepam, a sedative used to relieve anxiety | Drug | Lorazepam administration prior to IUD insertion procedure |
| Ibuprofen 800 mg800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain | Drug | Lorazepam administration prior to IUD insertion procedure |
Primary outcome
Visual Analogue Scale for Pain
Time frame: before and after the procedure (up to 1 hour)
Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain).
Visual Analogue Scale for Anxiety
Time frame: before and after the procedure (up to 1 hour)
Participant will be asked to rate their anxiety on a scale of 0 (no anxiety) to 10 (severe anxiety).
6 secondary outcomes
Mean Pain Scores for Nulliparous and Multiparous Participants
Time frame: before and after the procedure (up to 1 hour)
Mean Anxiety Scores for Nulliparous and Multiparous Participants
Time frame: before and after the procedure (up to 1 hour)
Number of Participants Recruited
Time frame: up to 2 months (estimated time period of recruitment)
Number of Participants with lorazepam prescription adherence
Time frame: up to 2 months (estimated time period of recruitment)
Number of Participants Who Completed All Surveys
Time frame: up to 2 months (estimated time period of recruitment)
Qualitative Measure: Participant Experience
Time frame: post-procedure (up to 1 hour)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Jensena Carlson, MD principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lorazepam 1 mg and Ibuprofen 800 mg in people with Pain and IUD, run by University of Wisconsin, Madison 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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 30 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Pain (time frame: before and after the procedure (up to 1 hour)). 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 30 Oct 2025; AzTrials last refreshed its copy on 27 Oct 2026.