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Trial record 21 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

Efficacy and Safety Oral Contraceptive Study

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: NCT00185484
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Rate of unintended pregnancies (Pearl index) [ Time Frame: 13 cycles of 28 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Pearl index study
Change History Complete list of historical versions of study NCT00185484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • Physical and gynecological examination [ Time Frame: screening, cycle 6 and final examination ]
  • Vital signs [ Time Frame: each visit ]
  • Body weight [ Time Frame: each visit ]
  • Cervical smear [ Time Frame: each visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Safety data
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Oral Contraceptive Study
Official Title  ICMJE Multi-center, Open, Uncontrolled Study to Investigate the Efficacy and Safety of the Oral Contraceptive SH T 186 D Containing 0.02 mg Ethinylestradiol-b-cyclodextrin Clathrate and 3 mg Drospirenone in a 24-day Regimen for 13 Cycles in 1010 Healthy Female Volunteers
Brief Summary The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2014)
1113
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy woman requesting contraception
  • Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

Exclusion Criteria:

  • Any conditions might interfere study outcome
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Czech Republic,   Hungary,   Italy,   Latvia,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT00185484
Other Study ID Numbers  ICMJE 91353
308021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP