Pearl Index Study With Low Dose Combined Oral Contraceptive - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00220324

Purpose

The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Condition	Intervention	Phase
Contraception	Drug: Minisiston (SH D00342A)	Phase III

MedlinePlus related topics: Birth Control

Drug Information available for: Ethinyl estradiol-norgestrel combination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prospective, Multicenter, Open-Label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers

Further study details as provided by Bayer:

Primary Outcome Measures:

Pearl Index [ Time Frame: After 13 cycles of intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bleeding pattern [ Time Frame: After 13 cycles ] [ Designated as safety issue: No ]
Safety parameters [ Time Frame: After 13 cycles ] [ Designated as safety issue: Yes ]

Enrollment:	840
Study Start Date:	February 2004
Study Completion Date:	November 2005

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Minisiston (SH D00342A) Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval

Detailed Description:

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy women requiring contraception

Exclusion Criteria:

Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220324

Locations

Germany

Berlin, Germany, 10179

Berlin, Germany, 10247

Berlin, Germany, 10409

Berlin, Germany, 12435

Berlin, Germany, 13507
Germany, Niedersachsen

Hannover, Niedersachsen, Germany, 30159
Germany, Sachsen

Leipzig, Sachsen, Germany, 04277

Dresden, Sachsen, Germany, 01108

Dresden, Sachsen, Germany, 01067

Dresden, Sachsen, Germany, 01324

Leipzig, Sachsen, Germany, 04207

Dresden, Sachsen, Germany, 01099

Leipzig, Sachsen, Germany, 04279

Großpösna, Sachsen, Germany, 04463
Germany, Sachsen-Anhalt

Jessen, Sachsen-Anhalt, Germany, 06917

Aschersleben, Sachsen-Anhalt, Germany, 06449

Magdeburg, Sachsen-Anhalt, Germany, 39126

Halberstadt, Sachsen-Anhalt, Germany, 38821

Halberstadt, Sachsen-Anhalt, Germany, 38820

Magdeburg, Sachsen-Anhalt, Germany, 39112

Magdeburg, Sachsen-Anhalt, Germany, 39120

Burg, Sachsen-Anhalt, Germany, 39288

Egeln, Sachsen-Anhalt, Germany, 39435
Germany, Thüringen

Weida, Thüringen, Germany, 07579

Suhl, Thüringen, Germany, 98527

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91313, 307987
Study First Received:	September 16, 2005
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00220324 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Contraception

Study placed in the following topic categories:

Contraceptive Agents
Contraceptives, Oral
Estradiol valerate
Contraceptive Agents, Female
Ethinyl Estradiol
Healthy
Estradiol 17 beta-cypionate
Contraceptives, Postcoital

Hemorrhage
Estradiol
Contraceptives, Oral, Combined
Norgestrel
Levonorgestrel
Estradiol 3-benzoate
Ethinyl Estradiol-Norgestrel Combination
Polyestradiol phosphate

Additional relevant MeSH terms:

Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Ethinyl Estradiol-Norgestrel Combination
Reproductive Control Agents
Contraceptives, Postcoital
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009