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

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00185380

First received: September 13, 2005

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

Results First Received: December 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention
Condition:	Contraception
Interventions:	Drug: Levonorgestrel IUS (BAY86-5028, G04209B) Drug: Levonorgestrel IUS (BAY86-5028, G04209C) Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Parous or nulliparous women in good general health and in need of contraception were recruited from medical clinics between April and Nov 2005.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Most screening failures were in-/exclusion criteria not met and over-screening. Randomized: 742 women, Treated: 738 women. Full analysis set (FAS), safety analysis set (SAF) and per protocol analysis set (PPS) were identical (738 subjects).

Reporting Groups

	Description
LCS12	Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
LCS16	Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
IUS20 (Mirena)	Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro

Participant Flow: Overall Study

	LCS12	LCS16	IUS20 (Mirena)
STARTED	240	246	256
Subjects Received Treatment	239	245	254
COMPLETED	174	174	182
NOT COMPLETED	66	72	74
Adverse Event	41	43	48
Lost to Follow-up	0	4	3
Pregnancy	1	4	0
Protocol Violation	2	2	1
Withdrawal by Subject	1	2	0
Failed insertion	1	1	2
Planned pregnancy	9	12	12
No need for contraception	3	3	3
Could not attend visits	2	0	4
personal reason	6	1	1

Baseline Characteristics

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Reporting Groups

	Description
LCS12	Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
LCS16	Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
IUS20 (Mirena)	Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
Total	Total of all reporting groups

Baseline Measures

	LCS12	LCS16	IUS20 (Mirena)	Total
Number of Participants [units: participants]	239	245	254	738
Age [units: years] Mean ± Standard Deviation	32.2 ± 5.44	32.1 ± 5.31	32.0 ± 5.21	32.1 ± 5.31
Gender ^[1] [units: participants]
Female	239	245	254	738
Male	0	0	0	0

[1]	Whilst 742 subjects were randomized, only 738 were treated.

Outcome Measures

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1. Primary:

Pearl Index [ Time Frame: Up to 3 years ]

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2. Secondary:

Number of Subjects With Total or Partial Expulsions [ Time Frame: Up to 3 years ]

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3. Secondary:

Bleeding Pattern by 90-day Reference Periods - Reference Period 1 [ Time Frame: day 1 to day 90 ]

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4. Secondary:

Bleeding Pattern by 90-day Reference Periods - Reference Period 2 [ Time Frame: day 91 to day 180 ]

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5. Secondary:

Bleeding Pattern by 90-day Reference Periods - Reference Period 3 [ Time Frame: day 181 to day 270 ]

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6. Secondary:

Bleeding Pattern by 90-day Reference Periods - Reference Period 4 [ Time Frame: day 271 to day 360 ]

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7. Secondary:

Bleeding Pattern by 90-day Reference Periods - Reference Period 12 [ Time Frame: day 991 to day 1080 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor is interested in the publication of the results of every study. As some of the information concerning the study drug and the sponsor's development activities may be strictly confidential, any publication manuscript (including conference contributins, etc.) must first be reviewed by the sponsor before its submission or presentation.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

Publications of Results:

Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012 Mar;97(3):616-22.e1-3. Epub 2012 Jan 4.

Responsible Party:	Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00185380 History of Changes
Other Study ID Numbers:	91412, 2004-002291-42, 308901
Study First Received:	September 13, 2005
Results First Received:	December 10, 2009
Last Updated:	May 25, 2012
Health Authority:	Finland: Finnish Medicines Agency Hungary: National Institute of Pharmacy Lithuania: State Medicine Control Agency - Ministry of Health Norway: Norwegian Medicines Agency Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

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