NCT03323671

Brief Summary

Preemptive analgesia before the release of pain mediators

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1.8 years until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

October 27, 2015

Last Update Submit

December 17, 2017

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrheapreemptive analgesia

Outcome Measures

Primary Outcomes (1)

  • change in the Degree of pain

    severity of pain according to visual pain analog scale

    4 months

Study Arms (2)

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

preemptive mefenamic acidDRUG

preemptive analgesia before menstrual pain

Also known as: ponstan forte
premenstruation group
mefenamic acidDRUG

mefenamic acid given only during menstruation

Also known as: ponstan forte
menstruation group

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Mefenamic Acid

Intervention Hierarchy (Ancestors)

Fenamatesortho-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Hanan Nabil, MD

    Manoura University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor Obstetrics and Gynecology

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 27, 2017

Study Start

August 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

EG(1)