Clinical trial NCT00528112: Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Official title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraception
Intrauterine
IUD
IUS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 2885
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years

Detailed description: Drop out-rate will be covered in Participant flow section.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

* Known or suspected pregnancy or is lactating.
* History of ectopic pregnancies.
* Any genital infection (until successfully treated).
* Abnormal uterine bleeding of unknown origin.

Primary outcomes:
measure: Pearl Index up to 3 Years
timeFrame: Up to 3 years
measure: Pearl Index for LCS16 up to 5 Years
timeFrame: Up to 5 years
Secondary outcomes:
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
timeFrame: Day 1 to Day 90
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
timeFrame: Day 91 to Day 180
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
timeFrame: Day 181 to Day 270
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
timeFrame: Day 271 to Day 360
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
timeFrame: Day 991 to Day 1080
measure: Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
timeFrame: Day 1 to Day 30
measure: Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
timeFrame: Day 31 to Day 60
measure: Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
timeFrame: Day 61 to Day 90
measure: Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
timeFrame: Day 91 to Day 120
measure: Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
timeFrame: Day 331 to Day 360
measure: Number of Participants With/Without Ovulation - Year 1
timeFrame: For six weeks in the second half of Year 1
measure: Number of Participants With/Without Ovulation - Year 2
timeFrame: For six weeks in the second half of Year 2
measure: Number of Participants With/Without Ovulation - Year 3
timeFrame: For six weeks in the second half of Year 3
measure: Average Total Cervical Score - Year 1
timeFrame: For six weeks in the second half of Year 1
measure: Average Total Cervical Score - Year 2
timeFrame: For six weeks in the second half of Year 2
measure: Average Total Cervical Score - Year 3
timeFrame: For six weeks in the second half of Year 3
measure: Classification of Endometrium - Year 1
timeFrame: At Year 1
measure: Classification of Endometrium - Year 2
timeFrame: At Year 2
measure: Classification of Endometrium - Year 3 / End of Study
timeFrame: At Year 3 / End of study
measure: Degree of User Overall Satisfaction With Study Treatment
timeFrame: At the end of study/Year 3
measure: Number of Participants With Partial or Total Expulsion
timeFrame: Up to 3 years
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
timeFrame: Day 1081 to Day 1170
measure: Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
timeFrame: Day 1711 to Day 1800
measure: Degree of User Overall Satisfaction With Study Treatment up to 5 Years
timeFrame: At the end of study/Year 5
measure: Number of Participants With Partial or Total Expulsion up to 5 Years
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Carmichael
country: United States
state: California
city: Pacific Palisades
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Boyton Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Marrero
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Chaska
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Moorestown
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Lanus Oeste
country: Argentina
state: Buenos Aires
city: San Isidro
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: Winnipeg
country: Canada
state: Manitoba
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Shawinigan
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Quebec
country: Canada
city: Santiago de Chile
country: Chile
city: Santiago
country: Chile
city: Espoo
country: Finland
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Joensuu
country: Finland
city: Kotka
country: Finland
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
city: Turku
country: Finland
city: Turku
country: Finland
city: COMPIEGNE cedex
country: France
city: Grenoble
country: France
city: Le Chesnay
country: France
city: Lille
country: France
city: Nimes
country: France
city: Quetigny
country: France
city: REIMS Cedex
country: France
city: Roanne
country: France
city: Szeged
country: Hungary
state: Csongrad
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Eger
country: Hungary
city: Esztergom
country: Hungary
city: Kecskemet
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szentes
country: Hungary
city: Torreón
country: Mexico
state: Coahuila
city: México, D.F.
country: Mexico
state: Distrito Federal
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Hermosillo
country: Mexico
state: Sonora
city: México, D.F.
country: Mexico
city: México, D.F.
country: Mexico
city: Alkmaar
country: Netherlands
city: Den Haag
country: Netherlands
city: Eindhoven
country: Netherlands
city: Heerlen
country: Netherlands
city: Helmond
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Elverum
country: Norway
city: Kolbotn
country: Norway
city: Larvik
country: Norway
city: Oslo
country: Norway
city: Trondheim
country: Norway
city: Göteborg
country: Sweden
city: Luleå
country: Sweden
city: Malmö
country: Sweden
city: Norrköping
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Uppsala
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Nahum GG, Kaunitz AM, Rosen K, Schmelter T, Lynen R. Ovarian cysts: presence and persistence with use of a 13.5mg levonorgestrel-releasing intrauterine system. Contraception. 2015 May;91(5):412-7. doi: 10.1016/j.contraception.2015.01.021. Epub 2015 Feb 7.
citation: 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.
citation: Nelson A, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Gemzell-Danielsson K. Two low-dose levonorgestrel intrauterine contraceptive systems: a randomized controlled trial. Obstet Gynecol. 2013 Dec;122(6):1205-13. doi: 10.1097/AOG.0000000000000019.
citation: Gemzell-Danielsson K, Apter D, Hauck B, Schmelter T, Rybowski S, Rosen K, Nelson A. The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial. PLoS One. 2015 Sep 17;10(9):e0135309. doi: 10.1371/journal.pone.0135309. eCollection 2015.