Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

NCT00528112 | Completed Phase 3 Results

• 5 other identifiers: 91665310442G04209FG04209G2007-000420-40
• Study Type: interventional
• Target: 2,885
• Locations: 11 countries
• Sites: 136

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

Conditions

Contraception

Keywords

Contraception; Intrauterine; IUD; IUS

Outcome Measures

Primary Outcomes (2)

• Pearl Index up to 3 Years

  The unadjusted 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 at risk of getting pregnant.

  Up to 3 years

• Pearl Index for LCS16 up to 5 Years

  The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.

  Up to 5 years

Secondary Outcomes (25)

• Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1

  Day 1 to Day 90

• Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2

  Day 91 to Day 180

• Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3

  Day 181 to Day 270

• Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4

  Day 271 to Day 360

• Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12

  Day 991 to Day 1080

Study Arms (2)

LCS12

EXPERIMENTAL

Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro

Drug: LCS12

LCS16

EXPERIMENTAL

Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro

Drug: LCS16

Interventions

LCS12 DRUG

Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h

LCS12

LCS16 DRUG

Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

LCS16

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (136)

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Mobile, Alabama, 36608, United States

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Glendale, Arizona, 85304, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85712, United States

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Carmichael, California, 95608, United States

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Pacific Palisades, California, 90272, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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San Diego, California, 92130, United States

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Torrance, California, 90502, United States

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Denver, Colorado, 80218, United States

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Littleton, Colorado, 80128, United States

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Boyton Beach, Florida, 33472, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33186, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30328, United States

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Decatur, Georgia, 30034, United States

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Boise, Idaho, 83702, United States

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Idaho Falls, Idaho, 83404, United States

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Chicago, Illinois, 60612, United States

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Evansville, Indiana, 47714, United States

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South Bend, Indiana, 46601, United States

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Marrero, Louisiana, 70072, United States

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Boston, Massachusetts, 02118, United States

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Kalamazoo, Michigan, 49009, United States

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Chaska, Minnesota, 55318, United States

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Chesterfield, Missouri, 63017, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89106, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89135, United States

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Moorestown, New Jersey, 08057, United States

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New Brunswick, New Jersey, 08903-2685, United States

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Albuquerque, New Mexico, 87102, United States

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New York, New York, 10032, United States

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New Bern, North Carolina, 28562, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45267, United States

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Columbus, Ohio, 43213, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97239, United States

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Jenkintown, Pennsylvania, 19046, United States

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Philadelphia, Pennsylvania, 19114, United States

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Pittsburgh, Pennsylvania, 15206, United States

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Pittsburgh, Pennsylvania, 15213-3180, United States

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Columbia, South Carolina, 29201, United States

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Chattanooga, Tennessee, 37404, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78748, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77054, United States

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Norfolk, Virginia, 23507, United States

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Seattle, Washington, 98105, United States

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Spokane, Washington, 99207, United States

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Lanús Oeste, Buenos Aires, 1824, Argentina

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San Isidro, Buenos Aires, B1642CLN, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425ASQ, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Calgary, Alberta, T2N 4L7, Canada

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Winnipeg, Manitoba, R3A 1M3, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Kingston, Ontario, K7L 2V7, Canada

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London, Ontario, N6A 4G5, Canada

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Waterloo, Ontario, N2L 6H6, Canada

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Montreal, Quebec, H1T 1P6, Canada

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Montreal, Quebec, H4P 2S4, Canada

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Québec, Quebec, G1S 2L6, Canada

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Québec, Quebec, G1V 4X7, Canada

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Shawinigan, Quebec, G9N 2H6, Canada

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Sherbrooke, Quebec, J1H 4J6, Canada

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Saskatoon, Saskatchewan, S7H 5M3, Canada

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Santiago, Chile

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Espoo, 02100, Finland

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Helsinki, 00100, Finland

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Helsinki, 00260, Finland

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Joensuu, 80100, Finland

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Kotka, 48100, Finland

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Kuopio, 70110, Finland

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Lahti, 15110, Finland

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Oulu, 90100, Finland

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Oulu, 90220, Finland

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Oulu, 90570, Finland

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Tampere, 33100, Finland

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Turku, 20100, Finland

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Turku, 20520, Finland

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Turku, 20540, Finland

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Compiègne, 60204, France

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Grenoble, 38043, France

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Le Chesnay, 78150, France

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Lille, 59037, France

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Nîmes, 30029, France

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Quetigny, 21800, France

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Reims, 51092, France

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Roanne, 42300, France

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Szeged, Csongrád megye, 6720, Hungary

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Békéscsaba, 5600, Hungary

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Budapest, 1116, Hungary

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Eger, 3300, Hungary

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Esztergom, 2500, Hungary

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Kecskemét, 6000, Hungary

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Nyíregyháza, 4400, Hungary

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Szentes, 6600, Hungary

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Torreón, Coahuila, 27000, Mexico

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México, D.F., Mexico City, 06700, Mexico

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Monterrey, Nuevo León, Mexico

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Hermosillo, Sonora, 83100, Mexico

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México, D.F., 06720, Mexico

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México, D.F., 11000, Mexico

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Alkmaar, 1817 MS, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Heerlen, 6419 PC, Netherlands

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Helmond, 5707 HA, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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The Hague, 2545 CH, Netherlands

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Utrecht, 3582 KE, Netherlands

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Elverum, 2403, Norway

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Kolbotn, 1411, Norway

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Larvik, 3264, Norway

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Oslo, 0364, Norway

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Trondheim, 7014, Norway

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Gothenburg, 416 64, Sweden

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Luleå, 972 33, Sweden

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Malmo, 217 44, Sweden

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Norrköping, 602 22, Sweden

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Örebro, 70185, Sweden

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Stockholm, 118 83, Sweden

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Stockholm, 141 86, Sweden

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Stockholm, 171 76, Sweden

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Stockholm, 182 88, Sweden

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Umeå, 90185, Sweden

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Uppsala, 75185, Sweden

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Related Publications (4)

• 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.

  PMID: 25661510 RESULT

• 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.

  PMID: 24726226 RESULT

• 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.

  PMID: 24240244 RESULT

• 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.

  PMID: 26378938 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: June 1, 2013
• Last Updated: January 25, 2017
• Results First Posted: September 24, 2012

Record last verified: 2016-12

Locations

AR (4); CA (13); US (57); SE (11); FI (14); ME (6); NO (5); FR (8); HU (8); CL (1); NL (9)