Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT). - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185458

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.

Condition	Intervention	Phase
Menopause	Device: Mirena	Phase III

MedlinePlus related topics: Birth Control Menopause

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment, Uncontrolled
Official Title:	A 36-Month Non-Comparative Study on Bleeding Profiles With Levonorgestrel Intrauterine System in Transition From Reproductive Age Contraception to Menopause Age Endometrial Protection During Estrogen Replacement Therapy.

Further study details as provided by Bayer:

Primary Outcome Measures:

Assessment of vaginal bleeding; numbers of bleeding and spotting days. [ Time Frame: Continuous treatment, for minimum 21 months maximum 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life, progestogenic and climacteric symptoms, continuation rates. [ Time Frame: Continuous treatment, for minimum 21 months maximum 60 months ] [ Designated as safety issue: No ]

Enrollment:	396
Study Start Date:	May 2000
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Device: Mirena LNG IUS for continuously for 9-48 months and thereafter together with continuous daily estradiol 2mg tablet or estradiol 1 mg tablet or estradiol patch 50 micro gr for 12 months

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

Ages Eligible for Study:	46 Years to 51 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185458

Locations

Belgium

HUY, Belgium, 4500

Gent, Belgium, 9000
Finland

Turku, Finland, 20520

Espoo, Finland, 02100

Turku, Finland, 20100
Netherlands

Heerlen, Netherlands, 6419 PC

Zaandam, Netherlands, 1502 DV

Zwijndrecht, Netherlands, 3331 LZ

Venlo, Netherlands, 5912 BL
United Kingdom

Newcastle upon Tyne, United Kingdom, NE4 6BE
United Kingdom, Cambridgeshire

Cambridge, Cambridgeshire, United Kingdom, CB23 2TN
United Kingdom, Dorset

Poole, Dorset, United Kingdom, BH15 2JB

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	90660, 300400
Study First Received:	September 13, 2005
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00185458 History of Changes
Health Authority:	Finland: National Agency for Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Estrogens
Contraceptive Agents
Estradiol valerate
Contraceptives, Oral
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Hemorrhage

Hormones
Estradiol
Estradiol 3-benzoate
Levonorgestrel
Polyestradiol phosphate
Menopause

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Levonorgestrel
Contraceptives, Oral
Physiological Effects of Drugs

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 13, 2009