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Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

Bayer logo

Bayer

Status and phase

Completed
Phase 2

Conditions

Contraception

Treatments

Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00185380
308901 (Other Identifier)
91412
2004-002291-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Enrollment

742 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women with or without children and good general health and in need of contraception.
  • Regular menstrual cycle without hormonal contraceptives.

Exclusion criteria

  • Pregnant or lactating.
  • Last delivery or abortion less than 12 weeks ago.
  • Previous pregnancies outside the womb.
  • Previous pelvic infections.
  • Abnormal bleeding.
  • Abnormal uterine cavity.
  • Climacteric signs.
  • Genital cancer.
  • Liver diseases.
  • Alcoholism or drug abuse.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

742 participants in 3 patient groups

LCS12
Experimental group
Description:
Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
Treatment:
Drug: Levonorgestrel IUS (BAY86-5028, G04209B)
LCS16
Experimental group
Description:
Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
Treatment:
Drug: Levonorgestrel IUS (BAY86-5028, G04209C)
IUS20 (Mirena)
Active Comparator group
Description:
Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
Treatment:
Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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