RCT comparing insertion of levonorgestrel releasing intrauterine system (Mirena) during the menstruation compared with random insertion beyond menstruations in patient-perceived pain.

Completed

• Conditions: intrauterine contraceptive; LNG-IUS; 10013326; 10029903

• Registration Number: NL-OMON40263
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Women who menstruate with a wish for LNG-IUS

Exclusion Criteria

* Women with an abnormal uterine cavity (myomas, polyps) determined by a TransVaginalUltrasound (TVU)
* Women with a failed insertion in a previous attempt, or with a LNG-IUS in situ and wish for change
* Women younger than 18 years
* Peri- or postmenopausal women
* Women with a positive pregnancy test or who had unprotected intercourse since their menses
* Amenorrhea after pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the patient-perceived pain during insertion of LNG-IUS using<br /><br>the VAS scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are ease of insertion and short-term outcomes, i.e.<br /><br>satisfaction, removal, expulsion, pregnancy rates, and bleeding pattern during<br /><br>a follow-up of three months.</p><br>