Efficacy of Mefenamic Acid and Hyoscine for Pain Relief D... | NCT01060696

Studies
Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women

NCT01060696

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Feb 2, 2010Estimated

Enrollment

138Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Mefenamic acid or Hyoscine or placebo

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Jan 31, 2010

First Submission Date that Met QC Criteria

Feb 1, 2010

First Posted Date

Feb 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Name	Class
Siriraj Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyoscine, Mefenamic acid, Placebo	Experimental	Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group	Drug: Mefenamic acid or Hyoscine or placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mefenamic acid or Hyoscine or placebo	Drug	Mefenamic acid 500 mg. single oral use 30 minutes before SIS Hyoscine 10 mg. single oral use 30 minutes before SIS Placebo single oral use 30 minutes before SIS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography		Before, during and after the procedure

Secondary Outcomes

Measure	Description	Time Frame
Patients satisfaction during saline infusion sonohysterography		After the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infertility female
no history of HSG or Hysteroscopy

Exclusion Criteria:

vaginal or pelvic infection
abnormal Pap smear
contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Singpetch Suksompong, Doctor		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj hospital Mahidol university		Bangkok	Bangkok	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D010146	Pain

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008528	Mefenamic Acid
D012601	Scopolamine
D002086	Butylscopolammonium Bromide

Ancestor Terms

ID	Term
D054361	Fenamates
D062367	ortho-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates

Browse Leaves

Not provided

Browse Branches

Not provided