Trial Condition(s):

Contraception, Contraception, Postcoital

Cross -over study to prove bioequivalence between two oral formulations of levonorgestrel (LEVEQ-2)

Bayer Identifier:

14355

ClinicalTrials.gov Identifier:

NCT01096498

EudraCT Number:

Not Available

Study Completed

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.

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.

Trial Summary

Enrollment Goal
24
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Levonorgestrel Emergency Pill (BAY86-5028)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Clinica de Enfermedades Cronicas y Procedimientos Especiales

Morelia, Mexico, 58256

Status
Completed
 

Trial Design