Trial Condition(s):

Menopause

Assessment of the transfer of using levonorgestrel intrauterine system (LNG IUS) as a contraceptive to using it as part of hormone replacement therapy (HRT).

Bayer Identifier:

90660

ClinicalTrials.gov Identifier:

NCT00185458

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 in the study is the pattern of any vaginal bleeding that occurs.

Inclusion Criteria
- Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms.
Exclusion Criteria
- Pregnancy or lactation.
 - Previous pelvic infections.
 - Abnormal bleeding.
 - Abnormal uterine cavity.
 - Uterine polyps.
 - Genital cancer.
 - Liver diseases.
 - Alcoholism or drug abuse.

Trial Summary

Enrollment Goal
394
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Atrium Medisch Centrum Parkstad

Heerlen, Netherlands, 6419 PC

Status
Completed
 
Locations

VieCuri - Medisch Centrum voor Noord-Limburg locatie Venlo

VENLO, Netherlands, 5912 BL

Status
Completed
 
Locations

Adenova Lääkärikeskus Oy

Espoo, Finland, 02100

Status
Completed
 
Locations

Turun Gynekologikeskus Oy

Turku, Finland, 20100

Status
Completed
 
Locations

Newcastle General Hospital

Newcastle upon Tyne, United Kingdom, NE4 6BE

Status
Completed
 
Locations

Poole Hospital NHS Trust

Poole, United Kingdom, BH15 2JB

Status
Completed
 
Locations

Dr. D. Leonard

HUY, Belgium, 4500

Status
Completed
 
Locations

UZ Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala, kantasairaala

Turku, Finland, 20520

Status
Completed
 
Locations

LCG Bioscience Bourn Hall Clinic

Cambridge, United Kingdom, CB23 2TN

Status
Completed
 
Locations

Zaans Medisch Centrum

Zaandam, Netherlands, 1502 DV

Status
Completed
 
Locations

Albert Schweitzer Ziekenhuis, locatie Zwijndrecht

Zwijndrecht, Netherlands, 3331 LZ

Status
Completed
 

Trial Design