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

Study Overview
=================
Brief 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

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

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Lidocaine-Prilocaine cream
* Drug: glyceryl trinitrate cream
* Drug: placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine-Prilocaine cream<br>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 | Drug: Lidocaine-Prilocaine cream<br>* 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<br>|
| Active Comparator: glyceryl trinitrate cream<br>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 | Drug: glyceryl trinitrate cream<br>* 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<br>|
| Placebo Comparator: placebo cream<br>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 | Drug: placebo cream<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the procedure | duration of the procedure from speculum in to speculum out | 10 minutes |