check_circleStudy Completed

Contraception, Contraception, Postcoital

Bayer Identifier:

14355

ClinicalTrials.gov Identifier:

NCT01096498

EudraCT Number:

Not Available

EU CT Number:

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

Trial purpose

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.

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 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.

Trial summary

Enrollment Goal
24
Trial Dates
February 2009 - March 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 event collection
    date_rangeTime Frame:
    Up to 8 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Open-label, randomized, crossover study to prove bioequivalence between Opxion® (levonorgestrel 0.75 mg from Bayer de Mexico) and Postday® (levonorgestrel 0.75 mg from Investigacion Farmaceutica), 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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