NCT06496854

Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Pain
• IUD

Interventions

Type	Name	Description
DRUG	Lorazepam 1 mg	1 mg oral lorazepam, a sedative used to relieve anxiety
DRUG	Ibuprofen 800 mg	800 mg ibuprofen, Nonsteroidal anti-inflammatory drug to treat pain

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-07-11
• Last updated: 2025-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study