Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00528112

Purpose

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 effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years.

Condition	Intervention	Phase
Contraception	Drug: G04209F Drug: G04209G	Phase III

MedlinePlus related topics: Birth Control

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women

Further study details as provided by Bayer:

Primary Outcome Measures:

Pregnancy rate [ Time Frame: 3 year treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Drop out -rate, expulsion of the IUS, Vaginal bleeding patterns, dysmenorrhea [ Time Frame: 3 year treatment ] [ Designated as safety issue: Yes ]

Enrollment:	2820
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: G04209F Intrauterine system (IUS) with Levonorgestrel
Arm 2: Experimental	Drug: G04209G Intrauterine system (IUS) with Levonorgestrel

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528112

Show 132 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	91665, 310442, G04209F, G04209G, Eudra CT No:2007-000420-40
Study First Received:	September 11, 2007
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00528112
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Contraception
Intrauterine
IUD
IUS

Study placed in the following topic categories:

Levonorgestrel

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral
Physiological Effects of Drugs

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009