check_circleStudy Completed
Contraceptives, Postcoital
Bayer Identifier:
14782
ClinicalTrials.gov Identifier:
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
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal
32Trial Dates
September 2009 - September 2009Phase
Phase 1Could I Receive a placebo
NoProducts
Levonorgestrel Emergency Pill (BAY86-5028)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Clinica de Enfermedades Cronicas y Procedimientos Especiales | Morelia, 58256, Mexico |
Primary Outcome
- Least square estimator of average maximum plasmatic concentration (log transformed)date_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Least square estimator of area under the pharmacokinetic curve (log transformed)date_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time at which maximum concentration is reacheddate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Area under the pharmacokinetic curve from time=0 to last blood sampledate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Half life of plasmatic concentration of study drugdate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Clearance constant of plasmatic concentration of study drugdate_rangeTime Frame:After 2 monthsenhanced_encryptionNoSafety Issue:
- Adverse events collectiondate_rangeTime Frame:Up to 8 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2