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Comparative Cycle Control Europe

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.
 
ClinicalTrials.gov Identifier: NCT00185367
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 15, 2011
Sponsor:
Information provided by:
Bayer

Brief Summary:
The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

Condition or disease Intervention/treatment Phase
Contraception Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) Drug: SH D 593 B (Miranova) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 798 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.
Study Start Date : March 2005
Actual Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Arm 1 Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-2: 3.0 mg EV; Day 3-7: 2.0 mg EV + 2.0 mg DNG; Day 8-24: 2.0 mg EV + 3.0 mg DNG; Day 25-26: 1.0 mg EV; Day 27-28: placebo;In addition SH D 593 B (Miranova) matching placebo

Active Comparator: Arm 2 Drug: SH D 593 B (Miranova)
7 cycles each consisting of 28 days (no tablet-free intervals); Day 1-21: 0.02 mg EE + 0.10 mg LNG; Day 22-28: placebo; In addition EV/DNG (Qlaira, BAY86-5027, SH T00658K) matching placebo




Primary Outcome Measures :
  1. Bleeding pattern [ Time Frame: 7 treatment cycles each consisting of 28 days ]
  2. Number of unintended pregnancies [ Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days ]

Secondary Outcome Measures :
  1. Adverse event collection [ Time Frame: 7 treatment cycles each consisting of 28 days and follow-up period of 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female volunteers aged between 18 and 50 years requiring contraception

Exclusion Criteria:

  • Pregnancy or lactation
  • Any conditions that might interfere with the outcome as well as all contraindications for OC use

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 ClinicalTrials.gov identifier (NCT number): NCT00185367


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00185367    
Other Study ID Numbers: 90883
EudraCT: 2004-001613-34
304004
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011