NCT02905058

Brief Summary

IUD can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the IUD insertion tube, and removing the tube; and placement of the device in the uterus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

September 14, 2016

Last Update Submit

November 11, 2017

Conditions

Pain Relief

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during IUD insertion

    5 minutes

Study Arms (2)

Ketoprofen

EXPERIMENTAL

women will take one tablet 150 mg one hour before the procedure

Drug: Ketoprofen

Placebo

PLACEBO COMPARATOR

women will take one placebo tablet one hour before the procedure

Drug: placebo

Interventions

KetoprofenDRUG

oral non-steroidal antiinflammatory drug

Also known as: bi profenid
Ketoprofen
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women not taken misoprostol prior to insertion
  • No contraindication to Non-steroidal drugs
  • Women who will accept to participate in the study

You may not qualify if:

  • Any contraindication to device placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Ketoprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

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

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

October 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

EG(1)