check_circleStudy Completed

Contraceptives, Postcoital

Bayer Identifier:

14782

ClinicalTrials.gov Identifier:

NCT01073904

EudraCT Number:

Not Available

EU CT Number:

Not Available
Cross-over study to prove bioequivalence between two oral formulations of levonorgestrel 1.5 mg

Trial purpose

A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years
  • - Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.
  • - History of illnesses or any organic abnormalities that could affect the results of the study.
    - History of tobacco or alcohol abuse 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.

Trial summary

Enrollment Goal
32
Trial Dates
September 2009 - September 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Levonorgestrel Emergency Pill (BAY86-5028)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Clinica de Enfermedades Cronicas y Procedimientos EspecialesMorelia, 58256, Mexico

Primary Outcome

  • Least square estimator of average maximum plasmatic concentration (log transformed)
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Least square estimator of area under the pharmacokinetic curve (log transformed)
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time at which maximum concentration is reached
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Area under the pharmacokinetic curve from time=0 to last blood sample
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Half life of plasmatic concentration of study drug
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Clearance constant of plasmatic concentration of study drug
    date_rangeTime Frame:
    After 2 months
    enhanced_encryption
    Safety Issue:
    No
  • Adverse events collection
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, randomized, crossover study to prove the bioequivalence between Opxion® (levonorgestrel 1.5 mg coated tablet from Bayer de Mexico) and Postinor 2® (levonorgestrel 1.5 mg tablet from Biofarma Natural CMD) in healthy volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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