Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion

NCT ID: NCT04311658

Last Updated: 2020-03-17

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2020-07-05

Brief Summary

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the aim of the study is to evaluate the safety and efficacy of isosorbide mononitrate vaginal administration in reducing pain during LNG-IUD insertion in adolescents and young women

Detailed Description

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Conditions

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Contraception

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 LNG-IUD insertion

Group Type EXPERIMENTAL

Isosorbide Mononitrate 40 MG

Intervention Type DRUG

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

placebo

one tablet of placebo vaginally 3 hours prior to LNG- IUD insertion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion

Interventions

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Isosorbide Mononitrate 40 MG

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

Intervention Type DRUG

Placebo

one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adolescents and young women requesting LNG-IUD insertion

Exclusion Criteria

* heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

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

Central Contacts

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AHMED SAMY

Role: CONTACT

+201100681167

Other Identifiers

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isosorbide mononitrate IUDs

Identifier Type: -

Identifier Source: org_study_id

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