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Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00528112
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : September 24, 2012
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Contraception Drug: LCS12 Drug: LCS16 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2885 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : August 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Drug: LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h

Experimental: LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Drug: LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h




Primary Outcome Measures :
  1. Pearl Index up to 3 Years [ Time Frame: 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.

  2. Pearl Index for LCS16 up to 5 Years [ Time Frame: Up to 5 years ]
    The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.


Secondary Outcome Measures :
  1. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1 [ Time Frame: Day 1 to Day 90 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  2. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2 [ Time Frame: Day 91 to Day 180 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  3. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3 [ Time Frame: Day 181 to Day 270 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  4. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4 [ Time Frame: Day 271 to Day 360 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  5. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12 [ Time Frame: Day 991 to Day 1080 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  6. Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1 [ Time Frame: Day 1 to Day 30 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  7. Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2 [ Time Frame: Day 31 to Day 60 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  8. Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3 [ Time Frame: Day 61 to Day 90 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  9. Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4 [ Time Frame: Day 91 to Day 120 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  10. Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12 [ Time Frame: Day 331 to Day 360 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  11. Number of Participants With/Without Ovulation - Year 1 [ Time Frame: For six weeks in the second half of Year 1 ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.

  12. Number of Participants With/Without Ovulation - Year 2 [ Time Frame: For six weeks in the second half of Year 2 ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.

  13. Number of Participants With/Without Ovulation - Year 3 [ Time Frame: For six weeks in the second half of Year 3 ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.

  14. Average Total Cervical Score - Year 1 [ Time Frame: For six weeks in the second half of Year 1 ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)

  15. Average Total Cervical Score - Year 2 [ Time Frame: For six weeks in the second half of Year 2 ]

    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.

    Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)


  16. Average Total Cervical Score - Year 3 [ Time Frame: For six weeks in the second half of Year 3 ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)

  17. Classification of Endometrium - Year 1 [ Time Frame: At Year 1 ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  18. Classification of Endometrium - Year 2 [ Time Frame: At Year 2 ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  19. Classification of Endometrium - Year 3 / End of Study [ Time Frame: At Year 3 / End of study ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  20. Degree of User Overall Satisfaction With Study Treatment [ Time Frame: At the end of study/Year 3 ]
    Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.

  21. Number of Participants With Partial or Total Expulsion [ Time Frame: Up to 3 years ]
    If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.

  22. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13 [ Time Frame: Day 1081 to Day 1170 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  23. Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20 [ Time Frame: Day 1711 to Day 1800 ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  24. Degree of User Overall Satisfaction With Study Treatment up to 5 Years [ Time Frame: At the end of study/Year 5 ]
    Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.

  25. Number of Participants With Partial or Total Expulsion up to 5 Years [ Time Frame: Up to 5 years ]
    If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528112


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Locations
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United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Glendale, Arizona, United States, 85304
Phoenix, Arizona, United States, 85032
Tucson, Arizona, United States, 85712
United States, California
Carmichael, California, United States, 95608
Pacific Palisades, California, United States, 90272
San Diego, California, United States, 92103
San Diego, California, United States, 92108
San Diego, California, United States, 92123
San Diego, California, United States, 92130
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80218
Littleton, Colorado, United States, 80128
United States, Florida
Boyton Beach, Florida, United States, 33472
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33186
West Palm Beach, Florida, United States, 33409
United States, Georgia
Atlanta, Georgia, United States, 30328
Decatur, Georgia, United States, 30034
United States, Idaho
Boise, Idaho, United States, 83702
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Evansville, Indiana, United States, 47714
South Bend, Indiana, United States, 46601
United States, Louisiana
Marrero, Louisiana, United States, 70072
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Michigan
Kalamazoo, Michigan, United States, 49009
United States, Minnesota
Chaska, Minnesota, United States, 55318
United States, Missouri
Chesterfield, Missouri, United States, 63017
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, Nevada
Las Vegas, Nevada, United States, 89106
Las Vegas, Nevada, United States, 89128
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Moorestown, New Jersey, United States, 08057
New Brunswick, New Jersey, United States, 08903-2685
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, New York
New York, New York, United States, 10032
United States, North Carolina
New Bern, North Carolina, United States, 28562
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45267
Columbus, Ohio, United States, 43213
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97239
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Philadelphia, Pennsylvania, United States, 19114
Pittsburgh, Pennsylvania, United States, 15206
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, South Carolina
Columbia, South Carolina, United States, 29201
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Memphis, Tennessee, United States, 38119
Nashville, Tennessee, United States, 37203
United States, Texas
Austin, Texas, United States, 78748
Houston, Texas, United States, 77030
Houston, Texas, United States, 77054
United States, Virginia
Norfolk, Virginia, United States, 23507
United States, Washington
Seattle, Washington, United States, 98105
Spokane, Washington, United States, 99207
Argentina
Lanus Oeste, Buenos Aires, Argentina, 1824
San Isidro, Buenos Aires, Argentina, B1642CLN
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425ASQ
Rosario, Santa Fe, Argentina, 2000
Canada, Alberta
Calgary, Alberta, Canada, T2N 4L7
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1M3
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Kingston, Ontario, Canada, K7L 2V7
London, Ontario, Canada, N6A 4G5
Waterloo, Ontario, Canada, N2L 6H6
Canada, Quebec
Montreal, Quebec, Canada, H1T 1P6
Montreal, Quebec, Canada, H4P 2S4
Shawinigan, Quebec, Canada, G9N 2H6
Sherbrooke, Quebec, Canada, J1H 4J6
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7H 5M3
Canada
Quebec, Canada, G1S 2L6
Quebec, Canada, G1V 4X7
Chile
Santiago de Chile, Chile
Santiago, Chile
Finland
Espoo, Finland, 02100
Helsinki, Finland, 00100
Helsinki, Finland, 00260
Joensuu, Finland, 80100
Kotka, Finland, 48100
Kuopio, Finland, 70110
Lahti, Finland, 15110
Oulu, Finland, 90100
Oulu, Finland, 90220
Oulu, Finland, 90570
Tampere, Finland, 33100
Turku, Finland, 20100
Turku, Finland, 20520
Turku, Finland, 20540
France
COMPIEGNE cedex, France, 60204
Grenoble, France, 38043
Le Chesnay, France, 78150
Lille, France, 59037
Nimes, France, 30029
Quetigny, France, 21800
REIMS Cedex, France, 51092
Roanne, France, 42300
Hungary
Szeged, Csongrad, Hungary, 6720
Bekescsaba, Hungary, 5600
Budapest, Hungary, 1116
Eger, Hungary, 3300
Esztergom, Hungary, 2500
Kecskemet, Hungary, 6000
Nyiregyhaza, Hungary, 4400
Szentes, Hungary, 6600
Mexico
Torreón, Coahuila, Mexico, 27000
México, D.F., Distrito Federal, Mexico, 06700
Monterrey, Nuevo Leon, Mexico
Hermosillo, Sonora, Mexico, 83100
México, D.F., Mexico, 06720
México, D.F., Mexico, 11000
Netherlands
Alkmaar, Netherlands, 1817 MS
Den Haag, Netherlands, 2545 CH
Eindhoven, Netherlands, 5623 EJ
Heerlen, Netherlands, 6419 PC
Helmond, Netherlands, 5707 HA
Hoofddorp, Netherlands, 2134 TM
Nijmegen, Netherlands, 6532 SZ
Rotterdam, Netherlands, 3079 DZ
Utrecht, Netherlands, 3582 KE
Norway
Elverum, Norway, 2403
Kolbotn, Norway, 1411
Larvik, Norway, 3264
Oslo, Norway, 0364
Trondheim, Norway, 7014
Sweden
Göteborg, Sweden, 416 64
Luleå, Sweden, 972 33
Malmö, Sweden, 217 44
Norrköping, Sweden, 602 22
Stockholm, Sweden, 118 83
Stockholm, Sweden, 141 86
Stockholm, Sweden, 171 76
Stockholm, Sweden, 182 88
Umeå, Sweden, 90185
Uppsala, Sweden, 75185
Örebro, Sweden, 70185
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00528112     History of Changes
Other Study ID Numbers: 91665
310442 ( Other Identifier: Company internal )
G04209F ( Other Identifier: Company internal )
G04209G ( Other Identifier: Company internal )
2007-000420-40 ( EudraCT Number )
First Posted: September 12, 2007    Key Record Dates
Results First Posted: September 24, 2012
Last Update Posted: January 25, 2017
Last Verified: December 2016

Keywords provided by Bayer:
Contraception
Intrauterine
IUD
IUS

Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral