NCT04079140

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_4

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

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

September 3, 2019

Last Update Submit

July 30, 2020

Conditions

IUD Insertion Pain

Outcome Measures

Primary Outcomes (1)

  • The difference in pain scores during intrauterine device insertion

    The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

    10 minutes

Study Arms (2)

dinoprostone

EXPERIMENTAL

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

Drug: Dinoprostone

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

DinoprostoneDRUG

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

dinoprostone
placeboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 22 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

You may not qualify if:

  • pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Cairo university

Giza, 11231, Egypt

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • AHMED SAMY

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

September 15, 2019

Primary Completion

November 30, 2019

Study Completion

December 10, 2019

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

EG(1)