Clinical Trial

Oral Hyoscine vs Lidocaine-Prilocaine Spray vs Placebo for HSG Pain Relief

Completed
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Summary
This single-centre, three-arm, randomised, double-blind, double-dummy, placebo-controlled trial evaluated the efficacy and safety of oral hyoscine butylbromide, topical lidocaine-prilocaine spray and placebo for reducing pain during hysterosalpingography in women with primary infertility. Pain was self-rated using an 11-point numerical rating scale at predefined procedural time points, including cervical instrumentation and uterine filling.
Protocol Amendment History 4 changes
critical Trial completed 2026-06-12
critical Primary endpoint(s) modified 2026-06-12
notable Primary completion pushed: 2026-03-01 -> 2026-04-01 2026-06-12
minor Completion pushed: 2026-03-30 -> 2026-04-30 2026-06-12
Trial Details
NCT Number NCT07383571
Lead Sponsor Cairo University
Collaborators: Aljazeera Hospital
Conditions Hysterosalpingography
Enrollment 102 participants
Start Date 2025-10-03
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-11