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

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Contraception

Treatments: Drug: Isosorbide Mononitrate 40 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04311658

isosorbide mononitrate IUDs

Details and patient eligibility

About

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

Enrollment: 88 estimated patients

Sex: Female

Ages: 14 to 25 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Isosorbide Mononitrate

Experimental group

Description:

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

Treatment:

Drug: Isosorbide Mononitrate 40 MG

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo