Preemptive Analgesia for Primary Dysmenorrhoea | NCT03323671

Studies
Preemptive Analgesia for Primary Dysmenorrhoea

NCT03323671

Sponsor

Hanan Nabil

Status

Completed

Last Update Posted

Dec 19, 2017Actual

Enrollment

84Actual

Phase

Phase 2Phase 3

Conditions

Primary Dysmenorrhea

Interventions

preemptive mefenamic acid
mefenamic acid

Countries

Egypt

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Oct 27, 2015

First Submission Date that Met QC Criteria

Oct 24, 2017

First Posted Date

Oct 27, 2017Actual

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

Dec 17, 2017

Last Update Posted Date

Dec 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Preemptive analgesia before the release of pain mediators

Detailed Description

spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea.

Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea.

Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
premenstruation group	Experimental	preemptive mefenamic acid 500mg tablets every 8 hours starting 2 days before anticipated menstruation and during the first 2 days of the cycle	Drug: preemptive mefenamic acid
menstruation group	Experimental	mefenamic acid 500mg tablets every 8 hours during the first 2 days of the cycle	Drug: mefenamic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preemptive mefenamic acid	Drug	preemptive analgesia before menstrual pain	premenstruation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in the Degree of pain	severity of pain according to visual pain analog scale	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

nulliparous ladies
with regular menstrual cycle pattern
those experienced history of dysmenorrhea (primary or spasmodic)
patients able to sallow tables

Exclusion Criteria:

irregular cycles
any associated local causes( pelvic infection, endometriosis, fibroid or others)
patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain
gastric or duodenal ulcers or gastritis
other contraindications to non steroidal anti-inflammatory drugs
patients with severe diminution of vision or color discrimination
patients with any depressive or mood disorders
patients receiving any hormonal treatment

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hanan Nabil, MD	Manoura University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University		Al Mansurah		35516	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D008528	Mefenamic Acid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided