Comparative Efficacy of Lidocaine Spray Versus Vaginal Misoprostol in IUD Insertion

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: lidocaine spray; Drug: vaginal misoprostol; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04339049

lidocaine IUD

Details and patient eligibility

About

the aim of the present study is to compare the safety and efficacy of lidocaine spray versus misoprostol in reducing pain during IUD insertion in adolescents and nulliparous women

Enrollment: 147 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adolescent and young nulliparous women requesting IUD insertion

Exclusion criteria

• multiparous women, contraindications to IUD insertion or to study drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

147 participants in 3 patient groups, including a placebo group

lidocaine spray

Experimental group

Description:

four puffs (10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion

Treatment:

Drug: lidocaine spray

vaginal misoprostol

Active Comparator group

Description:

vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Treatment:

Drug: vaginal misoprostol

placebo

Placebo Comparator group

Description:

vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Treatment:

Drug: placebo