Cervical Lidocaine-Prilocaine Cream vs Glyceryl Trinitrate Cream in Nulliparous Women With LNG-IUD Insertion

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Contraception

Treatments: Drug: Lidocaine-Prilocaine cream; Drug: placebo cream; Drug: glyceryl trinitrate cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04355598

glyceryl trinitrate IUD

Details and patient eligibility

About

the aim of the present study is to compare safety and efficacy of cervical Lidocaine-Prilocaine cream versus glyceryl trinitrate cream on pain perception during levonorgestrel- intrauterine device insertion among nulliparous women: a randomized double-blind controlled trial

Enrollment: 195 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• young and adolescent women requesting LNG-IUD insertion

Exclusion criteria

• parous women and contraindications to LNG-IUD placement or to the study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 3 patient groups, including a placebo group

Lidocaine-Prilocaine cream

Experimental group

Description:

2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Treatment:

Drug: Lidocaine-Prilocaine cream

glyceryl trinitrate cream

Active Comparator group

Description:

2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Treatment:

Drug: glyceryl trinitrate cream

placebo cream

Placebo Comparator group

Description:

2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion

Treatment:

Drug: placebo cream