Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion (POST)

Bayer

Status: Completed

Conditions: Contraception

Treatments: Drug: Levonorgestrel IUS (Mirena, BAY86-5028); Device: Copper-IUD

Study type: Observational

Funder types: Industry

Identifiers

NCT01958684

16954

MA1310CN (Other Identifier)

Details and patient eligibility

About

To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.

Enrollment: 512 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reproductive women in good general health and requesting long-term contraception
• Applied the Cu-IUD or LNG-IUS immediately after first trimester surgical abortion
• History of regular cyclic menstrual periods
• Written ICF was obtained

Exclusion criteria

• Suspected septic abortion and incomplete abortion, as well as missed abortion
• The contraindications and warnings of the respective Summary of Product Characteristics of Mirena or prescribing information of Cu-IUDs must be followed

Trial design

512 participants in 2 patient groups

Group 1

Description:

The MIRENA intrauterine delivery system (initial release rate: 20 μg LNG /24 h)

Treatment:

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Group 2

Description:

Copper IUDs with different shape and with or without drugs

Treatment:

Device: Copper-IUD