the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04312048

Enrollment

110

Registered

2020-03-18

Start date

2020-04-15

Completion date

2020-11-30

Last updated

2021-01-20

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

Conditions

IUD Insertion Pain

Brief summary

The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women

Interventions

DRUGIsosorbide mononitrate

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

DRUGplacebo

one tablet of placebo vaginally 3 hours prior to copper IUD insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* nulliparous women requesting copper IUD device insertion

Exclusion criteria

* parous women, 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 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' 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

Countries

Egypt

Outcome results

None listed

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