NCT06767085

Brief Summary

To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_4

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 5, 2025

Last Update Submit

January 5, 2025

Conditions

Office Hysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain

    Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

    5 minutes

Secondary Outcomes (2)

  • Intensity of pain

    20 minutes

  • ease of insertion

    5 MINUTES

Study Arms (2)

lidocaine prilocaine

EXPERIMENTAL
Drug: Lidocaine-Prilocaine Topical

placebo

PLACEBO COMPARATOR
Drug: Saline spray

Interventions

Lidocaine-Prilocaine TopicalDRUG

lidocaine-prilocaine spray on the cervix and cervical canal 5-7 minutes prior to the procedure

lidocaine prilocaine
Saline sprayDRUG

saline spray on the cervix and cervical canal 5-7 minutes prior to the procedure

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

You may not qualify if:

  • Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

LidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Central Study Contacts

AHMED SAMY ALI ASHOUR, MD

CONTACT

01100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 5, 2025

First Posted

January 9, 2025

Study Start

February 5, 2025

Primary Completion

July 5, 2025

Study Completion

July 25, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01