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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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