Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2010-01-31
2010-09-30
Brief Summary
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The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Flexi ring FR01
Placebo: Flexi ring FR01
Intrauterine device, inserted once for 3 months
Flexi ring FR20
Placebo: Flexi ring FR20
Intrauterine device, inserted once for 3 months
Ultra low dose LCS
Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)
Intrauterine device, inserted once for 3 months
Interventions
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Placebo: Flexi ring FR01
Intrauterine device, inserted once for 3 months
Placebo: Flexi ring FR20
Intrauterine device, inserted once for 3 months
Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)
Intrauterine device, inserted once for 3 months
Eligibility Criteria
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Inclusion Criteria
* Age 18-40 years (inclusive)
* History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days)
* Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry.
* Confirmed uterine sound depth of 6 to 10 cm
Exclusion Criteria
* Sterilized
* Nulliparous
* Congenital or acquired uterine anomaly
* Vaginal or cesarean delivery within 8 weeks prior to insertion
18 Years
40 Years
FEMALE
Yes
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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Helsinki, , Finland
Kuopio, , Finland
Tampere, , Finland
Turku, , Finland
Den Helder, , Netherlands
Heerlen, , Netherlands
Zwijndrecht, , Netherlands
Örebro, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Countries
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Other Identifiers
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13830
Identifier Type: -
Identifier Source: org_study_id
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