Safety and Efficacy of the Effect of Isosorbide Mononitrate in Reducing Pain During Levonorgestrel-releasing Intrauterine Device Insertion
NCT04311658 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2020-03-17
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
Conditions
- Contraception
Interventions
- DRUG
-
Isosorbide Mononitrate 40 MG
one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion
- DRUG
-
one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion
Sponsors & Collaborators
-
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 25 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-30
- Primary Completion
- 2020-06-25
- Completion
- 2020-07-05
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