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Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

NCT ID: NCT00185380

Last Updated: 2015-06-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

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Detailed Description

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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.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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LCS12

Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro

Group Type EXPERIMENTAL

Levonorgestrel IUS (BAY86-5028, G04209B)

Intervention Type DRUG

Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years

LCS16

Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro

Group Type EXPERIMENTAL

Levonorgestrel IUS (BAY86-5028, G04209C)

Intervention Type DRUG

Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years

IUS20 (Mirena)

Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro

Group Type ACTIVE_COMPARATOR

Levonorgestrel IUS (Mirena, BAY86-5028)

Intervention Type DRUG

Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

Interventions

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Levonorgestrel IUS (BAY86-5028, G04209B)

Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years

Intervention Type DRUG

Levonorgestrel IUS (BAY86-5028, G04209C)

Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years

Intervention Type DRUG

Levonorgestrel IUS (Mirena, BAY86-5028)

Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with or without children and good general health and in need of contraception.
* Regular menstrual cycle without hormonal contraceptives.

Exclusion Criteria

* Pregnant or lactating.
* Last delivery or abortion less than 12 weeks ago.
* Previous pregnancies outside the womb.
* Previous pelvic infections.
* Abnormal bleeding.
* Abnormal uterine cavity.
* Climacteric signs.
* Genital cancer.
* Liver diseases.
* Alcoholism or drug abuse.
Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Espoo, , Finland

Site Status

Helsinki, , Finland

Site Status

Joensuu, , Finland

Site Status

Jyväskylä, , Finland

Site Status

Kotka, , Finland

Site Status

Kuopio, , Finland

Site Status

Lahti, , Finland

Site Status

Oulu, , Finland

Site Status

Oulu, , Finland

Site Status

Oulu, , Finland

Site Status

Tampere, , Finland

Site Status

Turku, , Finland

Site Status

Turku, , Finland

Site Status

Turku, , Finland

Site Status

Békéscsaba, , Hungary

Site Status

Eger, , Hungary

Site Status

Nyíregyháza, , Hungary

Site Status

Szeged, , Hungary

Site Status

Drammen, , Norway

Site Status

Elverum, , Norway

Site Status

Kolbotn, , Norway

Site Status

Larvik, , Norway

Site Status

Oslo, , Norway

Site Status

Trondheim, , Norway

Site Status

Gothenburg, , Sweden

Site Status

Huddinge, , Sweden

Site Status

Kalmar, , Sweden

Site Status

Luleå, , Sweden

Site Status

Norrköping, , Sweden

Site Status

Örebro, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Umeå, , Sweden

Site Status

Chesterfield, Derbyshire, United Kingdom

Site Status

Sheffield, South Yorkshire, United Kingdom

Site Status

Chesterfield, , United Kingdom

Site Status

Countries

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Finland Hungary Norway Sweden United Kingdom

References

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Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3. doi: 10.1016/j.fertnstert.2011.12.003. Epub 2012 Jan 4.

Reference Type RESULT
PMID: 22222193 (View on PubMed)

Apter D, Gemzell-Danielsson K, Hauck B, Rosen K, Zurth C. Pharmacokinetics of two low-dose levonorgestrel-releasing intrauterine systems and effects on ovulation rate and cervical function: pooled analyses of phase II and III studies. Fertil Steril. 2014 Jun;101(6):1656-62.e1-4. doi: 10.1016/j.fertnstert.2014.03.004. Epub 2014 Apr 14.

Reference Type RESULT
PMID: 24726226 (View on PubMed)

Other Identifiers

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2004-002291-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

308901

Identifier Type: OTHER

Identifier Source: secondary_id

91412

Identifier Type: -

Identifier Source: org_study_id

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