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

Contraception Clinical Trial

Official title:

Comparative 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04355598
• Other study ID #: glyceryl trinitrate IUD
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 30, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: AHMED SAMY
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 195
• Est. completion date: August 10, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Lidocaine-Prilocaine cream
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
• glyceryl trinitrate cream
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
• placebo cream
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain during LNG-IUD insertion	pain during LNG-IUD insertion evaluated by 10 cm Visual analog scale where 0=no pain and 10=worst pain imaginable	5 minutes
Secondary	duration of the procedure	duration of the procedure from speculum in to speculum out	10 minutes