Pearl Index Study With Low Dose Combined Oral Contraceptive

April 2, 2015 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10409
      • Berlin, Germany, 13507
      • Berlin, Germany, 10247
      • Berlin, Germany, 12435
      • Berlin, Germany, 10179
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
    • Sachsen
      • 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
    • Sachsen-Anhalt
      • 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
    • Thüringen
      • Suhl, Thüringen, Germany, 98527
      • Weida, Thüringen, Germany, 07579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unadjusted Pearl Index
Time Frame: After 13 cycles of intake
After 13 cycles of intake

Secondary Outcome Measures

Outcome Measure
Time Frame
Adjusted Pearl Index
Time Frame: After 13 cycles of intake
After 13 cycles of intake
Cumulative pregnancy rate
Time Frame: After 13 cycles of intake
After 13 cycles of intake
Bleeding pattern
Time Frame: After 13 cycles of intake
After 13 cycles of intake
Cycle control
Time Frame: After 13 cycles of intake
After 13 cycles of intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91313
  • 307987 (Other Identifier: Other company ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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