the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

NCT ID: NCT04312048

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2020-11-30

Brief Summary

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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

Detailed Description

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Conditions

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IUD Insertion Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Isosorbide Mononitrate

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

Group Type EXPERIMENTAL

Isosorbide mononitrate

Intervention Type DRUG

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

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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Isosorbide mononitrate

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* nulliparous women requesting copper IUD device insertion

Exclusion Criteria

* parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud alalfy, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Ahmed Samy

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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00249

Identifier Type: -

Identifier Source: org_study_id

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