Status:
COMPLETED
Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
Lead Sponsor:
Bayer
Conditions:
Menopause
Eligibility:
FEMALE
46-51 years
Phase:
PHASE3
Brief Summary
The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest i...
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Eligibility Criteria
Inclusion
- Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.
Exclusion
- Pregnancy or lactation.
- Previous pelvic infections.
- Abnormal bleeding.
- Abnormal uterine cavity.
- Uterine polyps.
- Genital cancer.
- Liver diseases.
- Alcoholism or drug abuse.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00185458
Start Date
May 1 2000
End Date
May 1 2008
Last Update
November 27 2013
Active Locations (12)
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1
Ghent, Belgium, 9000
2
Huy, Belgium, 4500
3
Espoo, Finland, 02100
4
Turku, Finland, 20100