NCT06496854

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2025

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

3 months

First QC Date

July 3, 2024

Last Update Submit

October 28, 2025

Conditions

PainIUD

Keywords

IUD insertion

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Scale for Pain

    Participant will be asked to rate their pain on a scale of 0 (no pain) to 10 (severe pain).

    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).

    before and after the procedure (up to 1 hour)

Secondary Outcomes (6)

  • Mean Pain Scores for Nulliparous and Multiparous Participants

    before and after the procedure (up to 1 hour)

  • Mean Anxiety Scores for Nulliparous and Multiparous Participants

    before and after the procedure (up to 1 hour)

  • Number of Participants Recruited

    up to 2 months (estimated time period of recruitment)

  • Number of Participants with lorazepam prescription adherence

    up to 2 months (estimated time period of recruitment)

  • Number of Participants Who Completed All Surveys

    up to 2 months (estimated time period of recruitment)

  • +1 more secondary outcomes

Study Arms (1)

Lorazepam administration prior to IUD insertion procedure

EXPERIMENTAL
Drug: Lorazepam 1 mgDrug: Ibuprofen 800 mg

Interventions

Lorazepam 1 mgDRUG

1 mg oral lorazepam, a sedative used to relieve anxiety

Lorazepam administration prior to IUD insertion procedure
Ibuprofen 800 mgDRUG

800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain

Lorazepam administration prior to IUD insertion procedure

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Family Medicine Residency Clinics

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Pain

Interventions

LorazepamIbuprofen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jensena Carlson, MD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 11, 2024

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)