NCT02709603

Brief Summary

Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

March 11, 2016

Last Update Submit

September 6, 2016

Conditions

Pain Relief With HSG

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during. hysterosalpingography by visual analog scale

    intraoperative

Secondary Outcomes (1)

  • Mean pain score after hysterosalpingography

    30 minutes

Study Arms (2)

Group A

EXPERIMENTAL

oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure

Drug: hyoscine butyl bromide

Group B

PLACEBO COMPARATOR

oral 2 tablets (PLACEBO) 30 minutes before the procedure

Drug: placebo

Interventions

hyoscine butyl bromideDRUG

oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure

Also known as: BUSCOPAN
Group A
placeboDRUG

oral placebo; 2 tablets 30 minutes before the procedure

Group B

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The infertile women who indicated for HSG.

You may not qualify if:

  • contraindications to Hyoscine or NSAID - known sensitivity to these drugs
  • known sensitivity to contrast media
  • abnormal uterine bleeding
  • genital tract infection
  • suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Ahmed Abbas

Asyut, Please Select, 002, Egypt

Location

MeSH Terms

Interventions

Butylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • ahmed abbas, MD

    Woman health hospital Assiut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
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

May 1, 2016

Study Completion

June 1, 2016

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

EG(2)