Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

NCT04079140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-07-31

No results posted yet for this study

Summary

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Conditions

  • IUD Insertion Pain

Interventions

DRUG

Dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.

DRUG

placebo

one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED SAMY · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2019-11-30
Completion
2019-12-10

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079140 on ClinicalTrials.gov