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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40263

Enrollment

120

Registered

2013-09-19

Start date

2014-05-19

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine contraceptive LNG-IUS

Interventions

insertion of LNG-IUS beyond menstruation.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who menstruate with a wish for LNG-IUS

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary outcome is the patient-perceived pain during insertion of LNG-IUS using the VAS scale.	—

Secondary

Measure	Time frame
Secondary outcomes are ease of insertion and short-term outcomes, i.e. satisfaction, removal, expulsion, pregnancy rates, and bleeding pattern during a follow-up of three months.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)