NCT02711358

Brief Summary

The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

4 months

First QC Date

March 14, 2016

Last Update Submit

November 28, 2016

Conditions

Family Planning

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during IUD insertion

    intraoperative

Study Arms (2)

indomethacin

EXPERIMENTAL

indomethacin suppositories

Drug: indomethacin suppositories

placebo

PLACEBO COMPARATOR

placebo suppositories

Drug: placebo

Interventions

indomethacin suppositoriesDRUG

The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure

indomethacin
placeboDRUG

The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

placebo

Eligibility Criteria

Age20 Years - 49 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 intrauterine device insertion
  • Women who will accept to participate in the study

You may not qualify if:

  • Any contraindication to intrauterine device placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 4
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

March 14, 2016

First Posted

March 17, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

EG(1)