Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion

Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion in Adolescents and Young Women

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04311658

Enrollment

Registered

2020-03-17

Start date

2020-03-30

Completion date

2020-07-05

Last updated

2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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

Interventions

DRUGIsosorbide Mononitrate 40 MG

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 25 Years

Healthy volunteers

Inclusion criteria

* adolescents and young women requesting LNG-IUD insertion

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
pain during IUD insertion	5 minutes	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.

Secondary

Measure	Time frame	Description
duration of IUD insertion	5 minutes	duration of IUD insertion from speculum in to speculum out in minutes

Contacts

Primary ContactAHMED SAMY

ahmedsamy8233@gmail.com+201100681167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026