NCT02709590

Brief Summary

The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

March 11, 2016

Last Update Submit

April 25, 2017

Conditions

Pain Relief With HSG

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during hysterosalpigography by visual analog scale

    intraoperative

Secondary Outcomes (2)

  • Mean pain score after hysterosalpigography

    30 minutes

  • side effects of medication

    30 minutes

Study Arms (2)

Group A

EXPERIMENTAL

oral diclofenac potassium plus lidocaine anesthetic cream placed into their cervix immediately before HSG

Drug: diclofenac potassium + lidocaine

Group B

PLACEBO COMPARATOR

oral placebo tablets plus placebo cream placed into their cervix immediately before HSG

Drug: placebo

Interventions

diclofenac potassium + lidocaineDRUG

patients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG

Also known as: combined therapy
Group A
placeboDRUG

patients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG

Group B

Eligibility Criteria

Age19 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • any patient came for HSG

You may not qualify if:

  • any patient has contraindication to HSG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

DiclofenacLidocainePsychotherapy, Multiple

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAminesPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 16, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

EG(1)