NCT04312048

Brief Summary

The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

April 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

March 14, 2020

Last Update Submit

January 16, 2021

Conditions

IUD Insertion Pain

Outcome Measures

Primary Outcomes (1)

  • pain during IUD insertion

    intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable.

    5 minutes

Secondary Outcomes (1)

  • duration of IUD insertion

    5 minutes

Study Arms (2)

Isosorbide Mononitrate

EXPERIMENTAL

one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion

Drug: Isosorbide mononitrate

placebo

PLACEBO COMPARATOR

one tablet of placebo vaginally 3 hours prior to copper IUD insertion

Drug: placebo

Interventions

Isosorbide mononitrateDRUG

one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion

Isosorbide Mononitrate
placeboDRUG

one tablet of placebo vaginally 3 hours prior to copper IUD insertion

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • nulliparous women requesting copper IUD device insertion

You may not qualify if:

  • parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Samy

Giza, 11231, Egypt

Location

MeSH Terms

Interventions

isosorbide-5-mononitrate

Study Officials

  • Mahmoud alalfy, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor obstetrics and gynecology

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 18, 2020

Study Start

April 15, 2020

Primary Completion

October 25, 2020

Study Completion

November 30, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

EG(1)