Phase 3 N=2,885 Randomized Prevention

Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

Contraception

Bottom Line

View on ClinicalTrials.gov: NCT00528112 ↗

Enrolled (actual)

2,885

Serious AEs

5.2%

Results posted

Sep 2012

Primary outcome: Primary: Pearl Index up to 3 Years — 0.33; 0.31 Pregnancies per 100 women years

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LCS12 (Drug); LCS16 (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Bayer
Primary completion: Jul 2011

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	—

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

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.

View full record on ClinicalTrials.gov →

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.