Pearl Index Study With Low Dose Combined Oral Contraceptive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220324
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Contraception Drug: Minisiston (SH D00342A) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : February 2004
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Unadjusted Pearl Index [ Time Frame: After 13 cycles of intake ]

Secondary Outcome Measures :
  1. Adjusted Pearl Index [ Time Frame: After 13 cycles of intake ]
  2. Cumulative pregnancy rate [ Time Frame: After 13 cycles of intake ]
  3. Bleeding pattern [ Time Frame: After 13 cycles of intake ]
  4. Cycle control [ Time Frame: After 13 cycles of intake ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00220324

Hannover, Niedersachsen, Germany, 30159
Aschersleben, Sachsen-Anhalt, Germany, 06449
Burg, Sachsen-Anhalt, Germany, 39288
Egeln, Sachsen-Anhalt, Germany, 39435
Halberstadt, Sachsen-Anhalt, Germany, 38820
Halberstadt, Sachsen-Anhalt, Germany, 38821
Jessen, Sachsen-Anhalt, Germany, 06917
Magdeburg, Sachsen-Anhalt, Germany, 39112
Magdeburg, Sachsen-Anhalt, Germany, 39120
Magdeburg, Sachsen-Anhalt, Germany, 39126
Dresden, Sachsen, Germany, 01067
Dresden, Sachsen, Germany, 01099
Dresden, Sachsen, Germany, 01108
Dresden, Sachsen, Germany, 01324
Großpösna, Sachsen, Germany, 04463
Leipzig, Sachsen, Germany, 04207
Leipzig, Sachsen, Germany, 04277
Leipzig, Sachsen, Germany, 04279
Suhl, Thüringen, Germany, 98527
Weida, Thüringen, Germany, 07579
Berlin, Germany, 10179
Berlin, Germany, 10247
Berlin, Germany, 10409
Berlin, Germany, 12435
Berlin, Germany, 13507
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00220324     History of Changes
Other Study ID Numbers: 91313
307987 ( Other Identifier: Other company ID )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Bayer:

Additional relevant MeSH terms:
Contraceptive Agents
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital