NCT04311658

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 14, 2020

Last Update Submit

March 14, 2020

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • pain during IUD insertion

    intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable.

    5 minutes

Secondary Outcomes (1)

  • duration of IUD insertion

    5 minutes

Study Arms (2)

Isosorbide Mononitrate

EXPERIMENTAL

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

Drug: Isosorbide Mononitrate 40 MG

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Isosorbide Mononitrate 40 MGDRUG

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

Isosorbide Mononitrate
PlaceboDRUG

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

placebo

Eligibility Criteria

Age14 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adolescents and young women requesting LNG-IUD insertion

You may not qualify if:

  • heavy vaginal bleeding,pregnancy, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

isosorbide-5-mononitrate

Central Study Contacts

AHMED SAMY

CONTACT

+201100681167ahmedsamy8233@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor obstetrics and gynecology

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 17, 2020

Study Start

March 30, 2020

Primary Completion

June 25, 2020

Study Completion

July 5, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03