ContraceptionPhase 3NCT00528112
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
A Phase 3 study testing LCS12 and LCS16 in people with Contraception, run by Bayer at 136 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- LCS12 and LCS16
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,885 participants
- Where
- 136 sitesin 11 countries
- Study dates
- Aug 2007to Jun 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Known or suspected pregnancy or is lactating.
- History of ectopic pregnancies.
- Any genital infection (until successfully treated).
- Abnormal uterine bleeding of unknown origin.
Trial locations and contacts
136 sites in 11 countries.
136 sites in 11 countries
United States57 sites
Study site
Albuquerque, New Mexico, 87102
Study site
Atlanta, Georgia, 30328
Study site
Austin, Texas, 78748
Study site
Boise, Idaho, 83702
Study site
Boston, Massachusetts, 02118
Study site
Boyton Beach, Florida, 33472
Study site
Carmichael, California, 95608
Study site
Chaska, Minnesota, 55318
Study site
Chattanooga, Tennessee, 37404
Study site
Chesterfield, Missouri, 63017
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45267
Study site
Columbia, South Carolina, 29201
Study site
Columbus, Ohio, 43213
Study site
Decatur, Georgia, 30034
Study site
Denver, Colorado, 80218
Study site
Evansville, Indiana, 47714
Study site
Glendale, Arizona, 85304
Study site
Houston, Texas, 77030
Study site
Houston, Texas, 77054
Study site
Idaho Falls, Idaho, 83404
Study site
Jacksonville, Florida, 32216
Study site
Jenkintown, Pennsylvania, 19046
Study site
Kalamazoo, Michigan, 49009
Study site
Las Vegas, Nevada, 89106
Study site
Las Vegas, Nevada, 89128
Study site
Las Vegas, Nevada, 89135
Study site
Lincoln, Nebraska, 68510
Study site
Littleton, Colorado, 80128
Study site
Marrero, Louisiana, 70072
Study site
Medford, Oregon, 97504
Study site
Memphis, Tennessee, 38119
Study site
Miami, Florida, 33186
Study site
Mobile, Alabama, 36608
Study site
Moorestown, New Jersey, 08057
Study site
Nashville, Tennessee, 37203
Study site
New Bern, North Carolina, 28562
Study site
New Brunswick, New Jersey, 08903-2685
Study site
New York, New York, 10032
Study site
Norfolk, Virginia, 23507
Study site
Pacific Palisades, California, 90272
Study site
Philadelphia, Pennsylvania, 19114
Study site
Phoenix, Arizona, 85032
Study site
Pittsburgh, Pennsylvania, 15206
Study site
Pittsburgh, Pennsylvania, 15213-3180
Study site
Portland, Oregon, 97239
Study site
San Diego, California, 92103
Study site
San Diego, California, 92108
Study site
San Diego, California, 92123
Study site
San Diego, California, 92130
Study site
Seattle, Washington, 98105
Study site
South Bend, Indiana, 46601
Study site
Spokane, Washington, 99207
Study site
Torrance, California, 90502
Study site
Tucson, Arizona, 85712
Study site
West Palm Beach, Florida, 33409
Study site
Winston-Salem, North Carolina, 27103
Finland14 sites
Study site
Espoo, 02100
Study site
Helsinki, 00100
Study site
Helsinki, 00260
Study site
Joensuu, 80100
Study site
Kotka, 48100
Study site
Kuopio, 70110
Study site
Lahti, 15110
Study site
Oulu, 90100
Study site
Oulu, 90220
Study site
Oulu, 90570
Study site
Tampere, 33100
Study site
Turku, 20100
Study site
Turku, 20520
Study site
Turku, 20540
Canada13 sites
Study site
Calgary, Alberta, T2N 4L7
Study site
Kingston, Ontario, K7L 2V7
Study site
London, Ontario, N6A 4G5
Study site
Montreal, Quebec, H1T 1P6
Study site
Montreal, Quebec, H4P 2S4
Study site
Québec, Quebec, G1S 2L6
Study site
Québec, Quebec, G1V 4X7
Study site
Saskatoon, Saskatchewan, S7H 5M3
Study site
Shawinigan, Quebec, G9N 2H6
Study site
Sherbrooke, Quebec, J1H 4J6
Study site
Waterloo, Ontario, N2L 6H6
Study site
Winnipeg, Manitoba, R3A 1M3
Study site
Winnipeg, Manitoba, R3E 3P4
Sweden11 sites
Study site
Gothenburg, 416 64
Study site
Luleå, 972 33
Study site
Malmö, 217 44
Study site
Norrköping, 602 22
Study site
Örebro, 70185
Study site
Stockholm, 118 83
Study site
Stockholm, 141 86
Study site
Stockholm, 171 76
Study site
Stockholm, 182 88
Study site
Umeå, 90185
Study site
Uppsala, 75185
Netherlands9 sites
Study site
Alkmaar, 1817 MS
Study site
Eindhoven, 5623 EJ
Study site
Heerlen, 6419 PC
Study site
Helmond, 5707 HA
Study site
Hoofddorp, 2134 TM
Study site
Nijmegen, 6532 SZ
Study site
Rotterdam, 3079 DZ
Study site
The Hague, 2545 CH
Study site
Utrecht, 3582 KE
France8 sites
Study site
Compiègne, 60204
Study site
Grenoble, 38043
Study site
Le Chesnay, 78150
Study site
Lille, 59037
Study site
Nîmes, 30029
Study site
Quetigny, 21800
Study site
Reims, 51092
Study site
Roanne, 42300
Hungary8 sites
Study site
Békéscsaba, 5600
Study site
Budapest, 1116
Study site
Eger, 3300
Study site
Esztergom, 2500
Study site
Kecskemét, 6000
Study site
Nyíregyháza, 4400
Study site
Szeged, Csongrád megye, 6720
Study site
Szentes, 6600
Mexico6 sites
Study site
Hermosillo, Sonora, 83100
Study site
México, D.F., Mexico City, 06700
Study site
México, D.F., 06720
Study site
México, D.F., 11000
Study site
Monterrey, Nuevo León
Study site
Torreón, Coahuila, 27000
Norway5 sites
Study site
Elverum, 2403
Study site
Kolbotn, 1411
Study site
Larvik, 3264
Study site
Oslo, 0364
Study site
Trondheim, 7014
Argentina4 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425ASQ
Study site
Lanús Oeste, Buenos Aires, 1824
Study site
Rosario, Santa Fe Province, 2000
Study site
San Isidro, Buenos Aires, B1642CLN
About this 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
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
Read the detailed description
Drop out-rate will be covered in Participant flow section.
- Conditions
- Contraception
- Being tested
- LCS12, LCS16
- Keywords
- Contraception, Intrauterine, IUD, IUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCS12Drug
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
LCS16Drug
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h
| Study group | Role | What they receive |
|---|---|---|
| LCS12 | Experimental | Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro Receives: Drug: LCS12 |
| LCS16 | Experimental | Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro Receives: Drug: LCS16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (25)
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.
Measured: Day 1 to Day 90
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.
Measured: Day 91 to Day 180
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.
Measured: Day 181 to Day 270
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.
Measured: Day 271 to Day 360
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.
Measured: Day 991 to Day 1080
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.
Measured: Day 1 to Day 30
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.
Measured: Day 31 to Day 60
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.
Measured: Day 61 to Day 90
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.
Measured: Day 91 to Day 120
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.
Measured: Day 331 to Day 360
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.
Measured: For six weeks in the second half of Year 1
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.
Measured: For six weeks in the second half of Year 2
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.
Measured: For six weeks in the second half of Year 3
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)
Measured: For six weeks in the second half of Year 1
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)
Measured: For six weeks in the second half of Year 2
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)
Measured: For six weeks in the second half of Year 3
Classification of Endometrium - Year 1
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Measured: At Year 1
Classification of Endometrium - Year 2
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Measured: At Year 2
Classification of Endometrium - Year 3 / End of Study
The histological evaluation of the endometrium examined the effects of progesterone on the endometrium
Measured: At Year 3 / End of study
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.
Measured: At the end of study/Year 3
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.
Measured: Up to 3 years
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.
Measured: Day 1081 to Day 1170
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.
Measured: Day 1711 to Day 1800
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.
Measured: At the end of study/Year 5
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528112
- Sponsor's protocol ID
- 91665
- Other IDs
- 310442, G04209F, G04209G, 2007-000420-40
- Status last verified
- Dec 2016
- First submitted
- 11 Sep 2007
- Last updated
- 25 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25661510Apter 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.
PubMed 24726226Nelson 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.
PubMed 24240244Gemzell-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.
PubMed 26378938
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00528112
- Acronym / sponsor ID
- 91665
- Conditions
- Contraception
- Keywords
- Contraception, Intrauterine, IUD, IUS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,885 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Posted 24 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCS12 | Experimental | Drug: LCS12Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro |
| LCS16 | Experimental | Drug: LCS16Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- Known or suspected pregnancy or is lactating.
- History of ectopic pregnancies.
- Any genital infection (until successfully treated).
- Abnormal uterine bleeding of unknown origin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCS12Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h | Drug | LCS12 |
| LCS16Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h | Drug | LCS16 |
Primary outcome
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.
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.
25 secondary outcomes
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1
Time frame: Day 1 to Day 90
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2
Time frame: Day 91 to Day 180
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3
Time frame: Day 181 to Day 270
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4
Time frame: Day 271 to Day 360
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12
Time frame: Day 991 to Day 1080
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1
Time frame: Day 1 to Day 30
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2
Time frame: Day 31 to Day 60
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3
Time frame: Day 61 to Day 90
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4
Time frame: Day 91 to Day 120
Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12
Time frame: Day 331 to Day 360
Number of Participants With/Without Ovulation - Year 1
Time frame: For six weeks in the second half of Year 1
Number of Participants With/Without Ovulation - Year 2
Time frame: For six weeks in the second half of Year 2
Number of Participants With/Without Ovulation - Year 3
Time frame: For six weeks in the second half of Year 3
Average Total Cervical Score - Year 1
Time frame: For six weeks in the second half of Year 1
Average Total Cervical Score - Year 2
Time frame: For six weeks in the second half of Year 2
Average Total Cervical Score - Year 3
Time frame: For six weeks in the second half of Year 3
Classification of Endometrium - Year 1
Time frame: At Year 1
Classification of Endometrium - Year 2
Time frame: At Year 2
Classification of Endometrium - Year 3 / End of Study
Time frame: At Year 3 / End of study
Degree of User Overall Satisfaction With Study Treatment
Time frame: At the end of study/Year 3
Number of Participants With Partial or Total Expulsion
Time frame: Up to 3 years
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13
Time frame: Day 1081 to Day 1170
Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20
Time frame: Day 1711 to Day 1800
Degree of User Overall Satisfaction With Study Treatment up to 5 Years
Time frame: At the end of study/Year 5
Number of Participants With Partial or Total Expulsion up to 5 Years
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25661510Nahum 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.
- Results publication: PubMed 24726226Apter 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.
- Results publication: PubMed 24240244Nelson 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.
- Derived from this study: PubMed 26378938Gemzell-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.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
136 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LCS12 and LCS16 in people with Contraception, run by Bayer at 136 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 136 sites in United States, Finland, Canada, Sweden, Netherlands and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearl Index up to 3 Years (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00528112, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.