Contraceptives, Postcoital
Conditions
Brief summary
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.
Interventions
DRUGLevonorgestrel Emergency Pill (BAY86-5028)
Single dose of 1.5 mg coated tablet
DRUGPostinor 2
Single dose of 1.5 mg tablet
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Least square estimator of average maximum plasmatic concentration (log transformed) | After 2 months |
| Least square estimator of area under the pharmacokinetic curve (log transformed) | After 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Half life of plasmatic concentration of study drug | After 2 months |
| Time at which maximum concentration is reached | After 2 months |
| Adverse events collection | Up to 8 weeks |
| Clearance constant of plasmatic concentration of study drug | After 2 months |
| Area under the pharmacokinetic curve from time=0 to last blood sample | After 2 months |
Countries
Mexico
Outcome results
None listed