Trial Condition(s):
Contraception
Levonorgestrel contraceptive intrauterine systems (LCS) Pearl Index study
Bayer Identifier:
91665
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Lanus Oeste, Argentina, 1824 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425ASQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1V 4X7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H4P 2S4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sherbrooke, Canada, J1H 4J6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H1T 1P6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winnipeg, Canada, R3E 3P4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kingston, Canada, K7L 2V7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 4G5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winnipeg, Canada, R3A 1M3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90570 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Joensuu, Finland, 80100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kotka, Finland, 48100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROANNE, France, 42300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lille, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site REIMS Cedex, France, 51092 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Le Chesnay, France, 78150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szeged, Hungary, 6720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bekescsaba, Hungary, 5600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eger, Hungary, 3300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nyiregyhaza, Hungary, 4400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Isidro, Argentina, B1642CLN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shawinigan, Canada, G9N 2H6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quebec, Canada, G1S 2L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saskatoon, Canada, S7H 5M3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Waterloo, Canada, N2L 6H6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 4L7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Chile, Chile | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kuopio, Finland, 70110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Espoo, Finland, 02100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lahti, Finland, 15110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20540 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nimes, France, 30029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szentes, Hungary, 6600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torreón, Mexico, 27000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 06700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 06720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Den Haag, Netherlands, 2545 CH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ALKMAAR, Netherlands, 1817 MS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROTTERDAM, Netherlands, 3079 DZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trondheim, Norway, 7014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kolbotn, Norway, 1411 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elverum, Norway, 2403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 141 86 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 118 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Luleå, Sweden, 972 33 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 75185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COMPIEGNE cedex, France, 60204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quetigny, France, 21800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grenoble, France, 38043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Esztergom, Hungary, 2500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kecskemet, Hungary, 6000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1116 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hermosillo, Mexico, 83100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monterrey, Mexico | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site México, D.F., Mexico, 11000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Utrecht, Netherlands, 3582 KE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hoofddorp, Netherlands, 2134 TM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6532 SZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site HELMOND, Netherlands, 5707 HA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heerlen, Netherlands, 6419 PC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Eindhoven, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Örebro, Sweden, 70185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Norrköping, Sweden, 602 22 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Malmö, Sweden, 217 44 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85712 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Bend, United States, 46601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Evansville, United States, 47714 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boise, United States, 83702 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Idaho Falls, United States, 83404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Norfolk, United States, 23507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oslo, Norway, 0364 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Larvik, Norway, 3264 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 90185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 416 64 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boyton Beach, United States, 33472 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jenkintown, United States, 19046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carmichael, United States, 95608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Medford, United States, 97504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site West Palm Beach, United States, 33409 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chattanooga, United States, 37404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kalamazoo, United States, 49009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pacific Palisades, United States, 90272 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mobile, United States, 36608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moorestown, United States, 08057 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89135 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Memphis, United States, 38119 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45267 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glendale, United States, 85304 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Bern, United States, 28562 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United States, 63017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marrero, United States, 70072 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Littleton, United States, 80128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Denver, United States, 80218 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torrance, United States, 90502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Brunswick, United States, 08903-2685 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213-3180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Las Vegas, United States, 89128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chaska, United States, 55318 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Austin, United States, 78748 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Decatur, United States, 30034 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
2
Primary Outcome
- Pearl Index up to 3 yearsThe 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.Timeframe: Up to 3 years
- Pearl Index for LCS16 up to 5 yearsThe unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years.Timeframe: Up to 5 years
Secondary Outcome
- Bleeding patterns in days by 90-day reference periods - reference period 1The 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.Timeframe: Day 1 to Day 90
- Bleeding patterns in days by 90-day reference periods - reference period 2The 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.Timeframe: Day 91 to Day 180
- Bleeding patterns in days by 90-day reference periods - reference period 3The 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.Timeframe: Day 181 to Day 270
- Bleeding patterns in days by 90-day reference periods - reference period 4The 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.Timeframe: Day 271 to Day 360
- Bleeding patterns in days by 90-day reference periods - reference period 12The 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.Timeframe: Day 991 to Day 1080
- Bleeding patterns in days by 30-day reference periods - reference period 1The 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.Timeframe: Day 1 to Day 30
- Bleeding patterns in days by 30-day reference periods - reference period 2The 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.Timeframe: Day 31 to Day 60
- Bleeding patterns in days by 30-day reference periods - reference period 3The 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.Timeframe: Day 61 to Day 90
- Bleeding patterns in days by 30-day reference periods - reference period 4The 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.Timeframe: Day 91 to Day 120
- Bleeding patterns in days by 30-day reference periods - reference period 12The 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.Timeframe: Day 331 to Day 360
- Number of participants with/without ovulation – Year 1Serum 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.Timeframe: For six weeks in the second half of Year 1
- Number of participants with/without ovulation – Year 2Serum 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.Timeframe: For six weeks in the second half of Year 2
- Number of participants with/without ovulation – Year 3Serum 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.Timeframe: For six weeks in the second half of Year 3
- Average total cervical score – Year 1Cervical 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)Timeframe: For six weeks in the second half of Year 1
- Average total cervical score – Year 2Cervical 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)Timeframe: For six weeks in the second half of Year 2
- Average total cervical score – Year 3Cervical 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)Timeframe: For six weeks in the second half of Year 3
- Classification of endometrium – Year 1The histological evaluation of the endometrium examined the effects of progesterone on the endometriumTimeframe: At Year 1
- Classification of endometrium – Year 2The histological evaluation of the endometrium examined the effects of progesterone on the endometriumTimeframe: At Year 2
- Classification of endometrium – Year 3 / End of studyThe histological evaluation of the endometrium examined the effects of progesterone on the endometriumTimeframe: At Year 3 / End of study
- Degree of user overall satisfaction with study treatmentOverall 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.Timeframe: At the end of study/Year 3
- Number of participants with partial or total expulsionIf 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.Timeframe: Up to 3 years
- Bleeding patterns in days by 90-day reference periods - reference period 13The 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.Timeframe: Day 1081 to Day 1170
- Bleeding patterns in days by 90-day reference periods - reference period 20The 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.Timeframe: Day 1711 to Day 1800
- Degree of user overall satisfaction with study treatment up to 5 yearsOverall 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.Timeframe: At the end of study/Year 5
- Number of participants with partial or total expulsion up to 5 yearsIf 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.Timeframe: Up to 5 years
Additional Information
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