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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel IUS (BAY86-5028, G04209B) (Drug); Levonorgestrel IUS (BAY86-5028, G04209C) (Drug); Levonorgestrel IUS (Mirena, BAY86-5028) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The purpose of this study is to investigate if drug doses lower than the one released from Mirenaģ would be as effective for contraception as Mirenaģ. 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.

Clinical Details

Official title: Multi-center, Open, Randomized, Dose Finding Phase II Study to Investigate Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) Releasing Different Amounts of Levonorgestrel Compared to MIRENA in Nulliparous and Parous Women in Need of Contraception.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Pearl Index

Secondary outcome:

Number of Subjects With Total or Partial Expulsions

Bleeding Pattern by 90-day Reference Periods - Reference Period 1

Bleeding Pattern by 90-day Reference Periods - Reference Period 2

Bleeding Pattern by 90-day Reference Periods - Reference Period 3

Bleeding Pattern by 90-day Reference Periods - Reference Period 4

Bleeding Pattern by 90-day Reference Periods - Reference Period 12

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. 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.

Eligibility

Minimum age: 21 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Espoo 02100, Finland

Helsinki 00100, Finland

Joensuu 80100, Finland

Jyväskylä 40620, Finland

Kotka 48100, Finland

Kuopio 70110, Finland

Lahti 15110, Finland

Oulu 90100, Finland

Oulu 90570, Finland

Oulu 90220, Finland

Tampere 33100, Finland

Turku 20100, Finland

Turku 20520, Finland

Turku 20540, Finland

Bekescsaba 5600, Hungary

Eger 3300, Hungary

Nyiregyhaza 4400, Hungary

Szeged 6725, Hungary

Drammen 3001, Norway

Elverum 2403, Norway

Kolbotn 1411, Norway

Larvik 3264, Norway

Oslo 0309, Norway

Trondheim 7014, Norway

Göteborg 411 35, Sweden

Huddinge 14186, Sweden

Kalmar 39231, Sweden

Luleå 972 33, Sweden

Norrköping 602 22, Sweden

Stockholm S-171 76, Sweden

Umeå 90185, Sweden

√Ėrebro 701 46, Sweden

Chesterfield S40 1SX, United Kingdom

Chesterfield, Derbyshire S40 4TF, United Kingdom

Sheffield, South Yorkshire S1 2PJ, United Kingdom

Additional Information

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Starting date: April 2005
Last updated: May 15, 2015

Page last updated: August 23, 2015

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