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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04311658
• Other study ID #: isosorbide mononitrate IUDs
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 30, 2020
• Est. completion date: July 5, 2020

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: AHMED SAMY
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: July 5, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Isosorbide Mononitrate 40 MG
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion
• Placebo
one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	duration of IUD insertion	duration of IUD insertion from speculum in to speculum out in minutes	5 minutes