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

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: IUD Insertion Pain

Treatments: Drug: Isosorbide mononitrate; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04312048

00249

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 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 copper IUD insertion

Treatment:

Drug: Isosorbide mononitrate

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo