NCT02901561

Brief Summary

The purpose of the investigators' study was to evaluate whether misoprostol will improve pain scores .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2016

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

Study Start

First participant enrolled

September 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

September 10, 2016

Last Update Submit

March 12, 2017

Conditions

Pain Relief

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during intrauterine device insertion

    5 minutes

Study Arms (2)

misoprostol 200

EXPERIMENTAL

misoprostol 200 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

Drug: misoprostol 200

misoprostol 400

ACTIVE COMPARATOR

misoprostol 400 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

Drug: misoprostol 400

Interventions

misoprostol 200DRUG
misoprostol 200
misoprostol 400DRUG
misoprostol 400

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 who will accept to participate in the study

You may not qualify if:

  • Any contraindication to IUD 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 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 10, 2016

First Posted

September 15, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)