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Pearl Index Study With Low Dose Combined Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00220324
First received: September 16, 2005
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Unadjusted Pearl Index [ Time Frame: After 13 cycles of intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adjusted Pearl Index [ Time Frame: After 13 cycles of intake ] [ Designated as safety issue: No ]
  • Cumulative pregnancy rate [ Time Frame: After 13 cycles of intake ] [ Designated as safety issue: No ]
  • Bleeding pattern [ Time Frame: After 13 cycles of intake ] [ Designated as safety issue: No ]
  • Cycle control [ Time Frame: After 13 cycles of intake ] [ Designated as safety issue: No ]

Enrollment: 840
Study Start Date: February 2004
Study Completion Date: November 2005
Arms Assigned Interventions
Experimental: Arm 1 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
Hannover, Niedersachsen, Germany, 30159
Aschersleben, Sachsen-Anhalt, Germany, 06449
Burg, Sachsen-Anhalt, Germany, 39288
Egeln, Sachsen-Anhalt, Germany, 39435
Halberstadt, Sachsen-Anhalt, Germany, 38821
Halberstadt, Sachsen-Anhalt, Germany, 38820
Jessen, Sachsen-Anhalt, Germany, 06917
Magdeburg, Sachsen-Anhalt, Germany, 39112
Magdeburg, Sachsen-Anhalt, Germany, 39126
Magdeburg, Sachsen-Anhalt, Germany, 39120
Dresden, Sachsen, Germany, 01324
Dresden, Sachsen, Germany, 01108
Dresden, Sachsen, Germany, 01099
Dresden, Sachsen, Germany, 01067
Großpösna, Sachsen, Germany, 04463
Leipzig, Sachsen, Germany, 04207
Leipzig, Sachsen, Germany, 04279
Leipzig, Sachsen, Germany, 04277
Suhl, Thüringen, Germany, 98527
Weida, Thüringen, Germany, 07579
Berlin, Germany, 10409
Berlin, Germany, 10247
Berlin, Germany, 10179
Berlin, Germany, 13507
Berlin, Germany, 12435
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

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00220324     History of Changes
Other Study ID Numbers: 91313, 307987
Study First Received: September 16, 2005
Last Updated: March 21, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Contraception

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

ClinicalTrials.gov processed this record on May 19, 2013