Pearl Index Study With Low Dose Combined Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00220324
First received: September 16, 2005
Last updated: April 1, 2014
Last verified: April 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 38820
Halberstadt, Sachsen-Anhalt, Germany, 38821
Jessen, Sachsen-Anhalt, Germany, 06917
Magdeburg, Sachsen-Anhalt, Germany, 39112
Magdeburg, Sachsen-Anhalt, Germany, 39126
Magdeburg, Sachsen-Anhalt, Germany, 39120
Dresden, Sachsen, Germany, 01067
Dresden, Sachsen, Germany, 01108
Dresden, Sachsen, Germany, 01099
Dresden, Sachsen, Germany, 01324
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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00220324     History of Changes
Other Study ID Numbers: 91313, 307987
Study First Received: September 16, 2005
Last Updated: April 1, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Contraception

Additional relevant MeSH terms:
Contraceptives, Oral
Contraceptive Agents
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014