NCT04500015

Brief Summary

To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system 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 2020

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

August 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

August 2, 2020

Last Update Submit

September 27, 2021

Conditions

IUCD Complication

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

Secondary Outcomes (2)

  • duration of IUD insertion

    10 minutes

  • Provider ease of insertion

    10 minutes

Study Arms (2)

INH

EXPERIMENTAL

3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

Drug: INH

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Placebo Comparator

Interventions

INHDRUG

3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

INH
Placebo ComparatorDRUG

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

Placebo Comparator

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadolescents and young women.
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 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)

Aswan University Hospital

Aswān, 81528, Egypt

Location

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind randomized controlled study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: double blind randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 5, 2020

Study Start

September 1, 2020

Primary Completion

June 30, 2021

Study Completion

August 30, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)