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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01096485
First received: March 30, 2010
Last updated: June 9, 2013
Last verified: June 2013
History of Changes

March 30, 2010
June 9, 2013
February 2009
March 2009   (final data collection date for primary outcome measure)
  • Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01096485 on ClinicalTrials.gov Archive Site
  • Time at which maximum concentration is reached [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Area under the pharmacokinetic curve from time=0 to time of last blood sample [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Clearance constant of plasmatic concentration of study drug [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Half life of plasmatic concentration of study drug [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Contraception
  • Contraception, Postcoital
  • 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
  • Experimental: Arm 1
    Intervention: Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
  • Active Comparator: Arm 2
    Intervention: Drug: Levonorgestrel (Postday)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01096485
13956
No
Medical Director, Bayer de Mexico S.A. de C.V.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2013

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