Phase 3
Completed N=2,885
Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study
Source: ClinicalTrials.gov NCT00528112 ↗Enrolled (actual)
2,885
Serious AEs
5.2%
Results posted
Sep 2012
Primary outcomePrimary: Pearl Index up to 3 Years — 0.33; 0.31 Pregnancies per 100 women years
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pearl Index up to 3 Years |
0.33; 0.31 | — |
| PRIMARY Pearl Index for LCS16 up to 5 Years |
0.29 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1 |
40.9; 39.7; 18.3; 17.7; 22.6; 21.9 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2 |
23.3; 21.1; 10.2; 8.7; 13.2; 12.3 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3 |
19.4; 16.3; 8.3; 6.3; 11.2; 10.0 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4 |
17.6; 14.3; 7.2; 5.1; 10.4; 9.1 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12 |
13.4; 10.2; 4.8; 3.3; 8.6; 6.9 | — |
| SECONDARY Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1 |
18.0; 17.3; 8.2; 8.1; 9.7; 9.2 | — |
| SECONDARY Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2 |
12.7; 12.9; 5.6; 5.5; 7.1; 7.3 | — |
| SECONDARY Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3 |
10.3; 9.5; 4.4; 4.1; 5.8; 5.4 | — |
| SECONDARY Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4 |
8.6; 7.8; 3.7; 3.2; 4.9; 4.6 | — |
| SECONDARY Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12 |
5.7; 4.6; 2.3; 1.6; 3.4; 3.0 | — |
| SECONDARY Number of Participants With/Without Ovulation - Year 1 |
13; 11; 1; 1 | — |
| SECONDARY Number of Participants With/Without Ovulation - Year 2 |
10; 9; 1; 1 | — |
| SECONDARY Number of Participants With/Without Ovulation - Year 3 |
11; 7; 0; 0 | — |
| SECONDARY Average Total Cervical Score - Year 1 |
3.067; 3.127 | — |
| SECONDARY Average Total Cervical Score - Year 2 |
3.358; 2.798 | — |
| SECONDARY Average Total Cervical Score - Year 3 |
2.837; 2.448 | — |
| SECONDARY Classification of Endometrium - Year 1 |
0; 0; 0; 0; 25; 22 | — |
| SECONDARY Classification of Endometrium - Year 2 |
0; 0; 0; 0; 19; 19 | — |
| SECONDARY Classification of Endometrium - Year 3 / End of Study |
0; 0; 0; 1; 24; 22 | — |
| SECONDARY Degree of User Overall Satisfaction With Study Treatment |
1; 1; 796; 842; 201; 177 | — |
| SECONDARY Number of Participants With Partial or Total Expulsion |
24; 30; 29; 16 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 13 |
9.6; 3.1; 6.6 | — |
| SECONDARY Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 20 |
9.3; 2.9; 6.4 | — |
| SECONDARY Degree of User Overall Satisfaction With Study Treatment up to 5 Years |
610; 70; 3; 1; 2 | — |
| SECONDARY Number of Participants With Partial or Total Expulsion up to 5 Years |
35; 19 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00528112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.