Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
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.
3 other identifiers
interventional
742
5 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2005
Typical duration for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 10, 2010
CompletedJune 10, 2015
May 1, 2015
3.7 years
September 13, 2005
December 10, 2009
May 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pearl Index
The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant.
Up to 3 years
Secondary Outcomes (6)
Number of Subjects With Total or Partial Expulsions
Up to 3 years
Bleeding Pattern by 90-day Reference Periods - Reference Period 1
day 1 to day 90
Bleeding Pattern by 90-day Reference Periods - Reference Period 2
day 91 to day 180
Bleeding Pattern by 90-day Reference Periods - Reference Period 3
day 181 to day 270
Bleeding Pattern by 90-day Reference Periods - Reference Period 4
day 271 to day 360
- +1 more secondary outcomes
Study Arms (3)
LCS12
EXPERIMENTALLevonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
LCS16
EXPERIMENTALLevonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
IUS20 (Mirena)
ACTIVE COMPARATORLevonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
Interventions
Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years
Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years
Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
Eligibility Criteria
You may qualify if:
- Women with or without children and good general health and in need of contraception.
- Regular menstrual cycle without hormonal contraceptives.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (35)
Unknown Facility
Espoo, 02100, Finland
Unknown Facility
Helsinki, 00100, Finland
Unknown Facility
Joensuu, 80100, Finland
Unknown Facility
Jyväskylä, 40620, Finland
Unknown Facility
Kotka, 48100, Finland
Unknown Facility
Kuopio, 70110, Finland
Unknown Facility
Lahti, 15110, Finland
Unknown Facility
Oulu, 90100, Finland
Unknown Facility
Oulu, 90220, Finland
Unknown Facility
Oulu, 90570, Finland
Unknown Facility
Tampere, 33100, Finland
Unknown Facility
Turku, 20100, Finland
Unknown Facility
Turku, 20520, Finland
Unknown Facility
Turku, 20540, Finland
Unknown Facility
Békéscsaba, 5600, Hungary
Unknown Facility
Eger, 3300, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Szeged, 6725, Hungary
Unknown Facility
Drammen, 3001, Norway
Unknown Facility
Elverum, 2403, Norway
Unknown Facility
Kolbotn, 1411, Norway
Unknown Facility
Larvik, 3264, Norway
Unknown Facility
Oslo, 0309, Norway
Unknown Facility
Trondheim, 7014, Norway
Unknown Facility
Gothenburg, 411 35, Sweden
Unknown Facility
Huddinge, 14186, Sweden
Unknown Facility
Kalmar, 39231, Sweden
Unknown Facility
Luleå, 972 33, Sweden
Unknown Facility
Norrköping, 602 22, Sweden
Unknown Facility
Örebro, 701 46, Sweden
Unknown Facility
Stockholm, S-171 76, Sweden
Unknown Facility
Umeå, 90185, Sweden
Unknown Facility
Chesterfield, Derbyshire, S40 4TF, United Kingdom
Unknown Facility
Sheffield, South Yorkshire, S1 2PJ, United Kingdom
Unknown Facility
Chesterfield, S40 1SX, United Kingdom
Related Publications (2)
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.
PMID: 22222193RESULTApter 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.
PMID: 24726226RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
April 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 10, 2015
Results First Posted
March 10, 2010
Record last verified: 2015-05