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Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

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: NCT00185224
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 15, 2011
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE September 10, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date July 15, 2011
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)		 Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment [ Time Frame: Baseline, Cycle 7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2005)		 Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)		 Measurement of PK parameters [ Time Frame: Cycle 4, Cycle 7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2005)		 Measurement of PK parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive
Official Title  ICMJE A Single-center, Open-label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipids, Hemostatic Variables, and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles, Including the Pharmacokinetics
Brief Summary The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.
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 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Contraception
Intervention  ICMJE
  • Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
    7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo
  • Drug: SH D00264A (Triquilar)
    7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
  • Active Comparator: Arm 2
    Intervention: Drug: SH D00264A (Triquilar)
Publications * Junge W, Mellinger U, Parke S, Serrani M. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clin Drug Investig. 2011;31(8):573-584. doi: 10.2165/11590220-000000000-00000.

*   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: April 23, 2009)		 58
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy female volunteers 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00185224
Other Study ID Numbers  ICMJE 90927
EudraCT: 2004-001614-13
301886
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Therapeutic Area Head, Bayer Healthcare AG
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Bayer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date July 2011

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