Status:

COMPLETED

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

Lead Sponsor:

Bayer

Conditions:

Contraception

Eligibility:

FEMALE

21-40 years

Phase:

PHASE2

Brief Summary

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 rando...

Detailed 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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

April 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2008

Estimated Enrollment :

742 Patients enrolled

Trial Details

Trial ID

NCT00185380

Start Date

April 1 2005

End Date

December 1 2008

Last Update

June 10 2015

Active Locations (35)

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Page 1 of 9 (35 locations)

1

Espoo, Finland, 02100

2

Helsinki, Finland, 00100

3

Joensuu, Finland, 80100

4

Jyväskylä, Finland, 40620