Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
NCT ID: NCT00185458
Last Updated: 2013-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
394 participants
INTERVENTIONAL
2000-05-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LNG IUS
Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
LNG IUS
LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
Interventions
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LNG IUS
LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous pelvic infections.
* Abnormal bleeding.
* Abnormal uterine cavity.
* Uterine polyps.
* Genital cancer.
* Liver diseases.
* Alcoholism or drug abuse.
46 Years
51 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Ghent, , Belgium
Huy, , Belgium
Espoo, , Finland
Turku, , Finland
Turku, , Finland
Heerlen, , Netherlands
Venlo, , Netherlands
Zaandam, , Netherlands
Zwijndrecht, , Netherlands
Cambridge, Cambridgeshire, United Kingdom
Poole, Dorset, United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Depypere HT, Hillard T, Erkkola R, Lukkari-Lax E, Kunz M, Rautiainen P, Schram JH. A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause. Eur J Obstet Gynecol Reprod Biol. 2010 Dec;153(2):176-80. doi: 10.1016/j.ejogrb.2010.08.017.
Other Identifiers
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300400
Identifier Type: OTHER
Identifier Source: secondary_id
90660
Identifier Type: -
Identifier Source: org_study_id