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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

NCT01096485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Contraception
  • Contraception, Postcoital

Interventions

DRUG

Levonorgestrel Emergency Pill (BAY86-5028/Opxion)

Single dose of 1.5 mg coated tablet

DRUG

Levonorgestrel (Postday)

Single dose of two 0.75 mg tablets

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096485 on ClinicalTrials.gov