Trial · NCT00185380

Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)

NCT00185380, Phase 2, Completed, Bayer; results first posted 2010-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS). Trials, record NCT00185380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00185380

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
NCT number: NCT00185380
Status: Completed
Phases: Phase 2
Enrollment: 742 participants, actual
Lead sponsor: Bayer
Conditions: Contraception
Interventions: Levonorgestrel IUS (BAY86-5028, G04209B), Levonorgestrel IUS (BAY86-5028, G04209C), Levonorgestrel IUS (Mirena, BAY86-5028)
First posted: 2005-09-16
Last updated: 2015-06-10
Other registries' IDs: eudract:2004-002291-42
Results first posted: 2010-03-10

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pearl Index	Up to 3 years	The 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 under risk of getting pregnant.
Secondary	Number of Subjects With Total or Partial Expulsions	Up to 3 years	The numbers of subjects with partial or total IUS expulsions (device displaced from its correct position within the uterus) were to be given by treatment.
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 1	day 1 to day 90	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 2	day 91 to day 180	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 3	day 181 to day 270	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 4	day 271 to day 360	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.
Secondary	Bleeding Pattern by 90-day Reference Periods - Reference Period 12	day 991 to day 1080	Subjects kept a bleeding diary and recorded any bleeding every day by category: none, spotting, light, normal or heavy. Any missing data were obtained by direct questioning.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pearl Index	Up to 3 years	All randomized women with a successful insertion were analyzed according to the treatment actually received and were included in the FAS, which was the set used for all safety and efficacy analyses. The PPS was identical to the FAS.	Number per 100 women years	MEDIAN
SECONDARY	Number of Subjects With Total or Partial Expulsions	Up to 3 years	The analysis was performed on the FAS (all subjects who had an IUS inserted).	participants	NUMBER
SECONDARY	Bleeding Pattern by 90-day Reference Periods - Reference Period 1	day 1 to day 90	The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.	days	MEAN
SECONDARY	Bleeding Pattern by 90-day Reference Periods - Reference Period 2	day 91 to day 180	The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.	days	MEAN
SECONDARY	Bleeding Pattern by 90-day Reference Periods - Reference Period 3	day 181 to day 270	The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.	days	MEAN
SECONDARY	Bleeding Pattern by 90-day Reference Periods - Reference Period 4	day 271 to day 360	The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.	days	MEAN
SECONDARY	Bleeding Pattern by 90-day Reference Periods - Reference Period 12	day 991 to day 1080	The analysis was performed on the FAS (all subjects with an insertion) and included subjects with bleeding or spotting or both.	days	MEAN

Source ClinicalTrials.gov

Results by group54

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pearl Index	LCS12		0.17	95% Confidence Interval 0.00 to 0.93	Number per 100 women years
Pearl Index	LCS16		0.82	95% Confidence Interval 0.27 to 1.92	Number per 100 women years
Pearl Index	IUS20 (Mirena)		0.00	95% Confidence Interval 0.00 to 0.59	Number per 100 women years
Number of Subjects With Total or Partial Expulsions	LCS12	total expulsion	0		participants
Number of Subjects With Total or Partial Expulsions	LCS16	total expulsion	3		participants
Number of Subjects With Total or Partial Expulsions	IUS20 (Mirena)	total expulsion	0		participants
Number of Subjects With Total or Partial Expulsions	LCS12	partial expulsion	1		participants
Number of Subjects With Total or Partial Expulsions	LCS16	partial expulsion	2		participants
Number of Subjects With Total or Partial Expulsions	IUS20 (Mirena)	partial expulsion	4		participants
Bleeding Pattern by 90-day Reference Periods - Reference Period 1	LCS12	Number of bleeding days (light, normal or heavy)	15.1	Standard Deviation 10.1	days

1 to 10 of 54Source ClinicalTrials.gov

See all 54 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	LCS12	240
Overall Study	STARTED	LCS16	246
Overall Study	STARTED	IUS20 (Mirena)	256
Overall Study	Subjects Received Treatment	LCS12	239
Overall Study	Subjects Received Treatment	LCS16	245
Overall Study	Subjects Received Treatment	IUS20 (Mirena)	254
Overall Study	COMPLETED	LCS12	174
Overall Study	COMPLETED	LCS16	174
Overall Study	COMPLETED	IUS20 (Mirena)	182
Overall Study	NOT COMPLETED	LCS12	66

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events222

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal distension	Gastrointestinal disorders	LCS12	40	239
other	Abdominal distension	Gastrointestinal disorders	LCS16	49	245
other	Abdominal distension	Gastrointestinal disorders	IUS20 (Mirena)	50	254
other	Abdominal pain	Gastrointestinal disorders	LCS12	19	239
other	Abdominal pain	Gastrointestinal disorders	LCS16	19	245
other	Abdominal pain	Gastrointestinal disorders	IUS20 (Mirena)	23	254
other	Nausea	Gastrointestinal disorders	LCS12	18	239
other	Nausea	Gastrointestinal disorders	LCS16	20	245
other	Nausea	Gastrointestinal disorders	IUS20 (Mirena)	22	254
other	Abdominal pain lower	Gastrointestinal disorders	LCS12	16	239

1 to 10 of 222Source ClinicalTrials.gov

See all 222 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LCS12
Total, all-cause mortality	LCS16
Total, all-cause mortality	IUS20 (Mirena)
Total, other adverse events	LCS12	187	239
Total, other adverse events	LCS16	198	245
Total, other adverse events	IUS20 (Mirena)	218	254
Total, serious adverse events	LCS12	12	239
Total, serious adverse events	LCS16	12	245
Total, serious adverse events	IUS20 (Mirena)	16	254

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22222193	RESULT	PubMed
24726226	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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