Study Completed

Contraception

Bayer Identifier:

91665

ClinicalTrials.gov Identifier:

NCT00528112

EudraCT Number:

2007-000420-40

EU CT Number:

Not Available

Levonorgestrel contraceptive intrauterine systems (LCS) Pearl Index study

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

Trial summary

Enrollment Goal

2885

Trial Dates

August 2007 - June 2013

Phase

Phase 3

Could I Receive a placebo

Products

Skyla (Levonorgestrel, BAY86-5028)

Accepts Healthy Volunteer

Yes

Where to participate

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

Primary Outcome

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.
Time Frame:
Up to 3 years
Safety Issue:
No
Pearl Index for LCS16 up to 5 years
The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.
Time Frame:
Up to 5 years
Safety Issue:
No

Secondary Outcome

Bleeding patterns in days by 90-day reference periods - reference period 1
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.
Time Frame:
Day 1 to Day 90
Safety Issue:
No
Bleeding patterns in days by 90-day reference periods - reference period 2
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.
Time Frame:
Day 91 to Day 180
Safety Issue:
No
Bleeding patterns in days by 90-day reference periods - reference period 3
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.
Time Frame:
Day 181 to Day 270
Safety Issue:
No
Bleeding patterns in days by 90-day reference periods - reference period 4
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.
Time Frame:
Day 271 to Day 360
Safety Issue:
No
Bleeding patterns in days by 90-day reference periods - reference period 12
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.
Time Frame:
Day 991 to Day 1080
Safety Issue:
No
Bleeding patterns in days by 30-day reference periods - reference period 1
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.
Time Frame:
Day 1 to Day 30
Safety Issue:
No
Bleeding patterns in days by 30-day reference periods - reference period 2
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.
Time Frame:
Day 31 to Day 60
Safety Issue:
No
Bleeding patterns in days by 30-day reference periods - reference period 3
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.
Time Frame:
Day 61 to Day 90
Safety Issue:
No
Bleeding patterns in days by 30-day reference periods - reference period 4
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.
Time Frame:
Day 91 to Day 120
Safety Issue:
No
Bleeding patterns in days by 30-day reference periods - reference period 12
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.
Time Frame:
Day 331 to Day 360
Safety Issue:
No
Number of participants with/without ovulation – 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.
Time Frame:
For six weeks in the second half of Year 1
Safety Issue:
No
Number of participants with/without ovulation – 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.
Time Frame:
For six weeks in the second half of Year 2
Safety Issue:
No
Number of participants with/without ovulation – 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.
Time Frame:
For six weeks in the second half of Year 3
Safety Issue:
No
Average total cervical score – 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)
Time Frame:
For six weeks in the second half of Year 1
Safety Issue:
No
Average total cervical score – 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)
Time Frame:
For six weeks in the second half of Year 2
Safety Issue:
No
Average total cervical score – 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)
Time Frame:
For six weeks in the second half of Year 3
Safety Issue:
No
Classification of endometrium – Year 1
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time Frame:
At Year 1
Safety Issue:
No
Classification of endometrium – Year 2
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time Frame:
At Year 2
Safety Issue:
No
Classification of endometrium – Year 3 / End of study
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Time Frame:
At Year 3 / End of study
Safety Issue:
No
Degree of user overall satisfaction with study treatment
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.
Time Frame:
At the end of study/Year 3
Safety Issue:
No
Number of participants with partial or total expulsion
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.
Time Frame:
Up to 3 years
Safety Issue:
No
Bleeding patterns in days by 90-day reference periods - reference period 13
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.
Time Frame:
Day 1081 to Day 1170
Safety Issue:
No
Bleeding patterns in days by 90-day reference periods - reference period 20
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.
Time Frame:
Day 1711 to Day 1800
Safety Issue:
No
Degree of user overall satisfaction with study treatment up to 5 years
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.
Time Frame:
At the end of study/Year 5
Safety Issue:
No
Number of participants with partial or total expulsion 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.
Time Frame:
Up to 5 years
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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