Cervical Lidocaine-Prilocaine Cream vs Glyceryl Trinitrate Cream in Nulliparous Women With LNG-IUD Insertion

NCT ID: NCT04355598

Last Updated: 2020-04-21

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

PHASE4

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-08-10

Brief Summary

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the aim of the present study is to compare safety and efficacy of cervical Lidocaine-Prilocaine cream versus glyceryl trinitrate cream on pain perception during levonorgestrel- intrauterine device insertion among nulliparous women: a randomized double-blind controlled trial

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

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lidocaine-Prilocaine cream

2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Group Type EXPERIMENTAL

Lidocaine-Prilocaine cream

Intervention Type DRUG

2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

glyceryl trinitrate cream

2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Group Type ACTIVE_COMPARATOR

glyceryl trinitrate cream

Intervention Type DRUG

2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

placebo cream

2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Group Type PLACEBO_COMPARATOR

placebo cream

Intervention Type DRUG

2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Interventions

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Lidocaine-Prilocaine cream

2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Intervention Type DRUG

glyceryl trinitrate cream

2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Intervention Type DRUG

placebo cream

2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* young and adolescent women requesting LNG-IUD insertion

Exclusion Criteria

* parous women and contraindications to LNG-IUD placement or to the study drugs.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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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glyceryl trinitrate IUD

Identifier Type: -

Identifier Source: org_study_id

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