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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel (LEVEQ-1)

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: NCT01096485
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : June 11, 2013
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE March 30, 2010
First Posted Date  ICMJE March 31, 2010
Last Update Posted Date June 11, 2013
Study Start Date  ICMJE February 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After 2 months ]
  • Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Time at which maximum concentration is reached [ Time Frame: After 2 months ]
  • Area under the pharmacokinetic curve from time=0 to time of last blood sample [ Time Frame: After 2 months ]
  • Clearance constant of plasmatic concentration of study drug [ Time Frame: After 2 months ]
  • Half life of plasmatic concentration of study drug [ Time Frame: After 2 months ]
  • Adverse events collection [ Time Frame: Up to 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
Official Title  ICMJE Open-label, Randomized, Crossover Study to Compare the Bioavailability of One Coated Tablet of Opxion® (Levonorgestrel 1.5 mg From Bayer de Mexico) vs. Two Tablets of Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers
Brief Summary A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Contraception
  • Contraception, Postcoital
Intervention  ICMJE
  • Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
    Single dose of 1.5 mg coated tablet
  • Drug: Levonorgestrel (Postday)
    Single dose of two 0.75 mg tablets
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
  • Active Comparator: Arm 2
    Intervention: Drug: Levonorgestrel (Postday)
Publications * Not Provided

*   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: March 30, 2010)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.

Exclusion Criteria:

  • History of illnesses or any organic abnormalities that could affect the results of the study.
  • History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs.
  • Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096485
Other Study ID Numbers  ICMJE 13956
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Director, Bayer de Mexico S.A. de C.V.
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date June 2013

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