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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg

NCT01073904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-04-03

No results posted yet for this study

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.

Conditions

  • Contraceptives, Postcoital

Interventions

DRUG

Levonorgestrel Emergency Pill (BAY86-5028)

Single dose of 1.5 mg coated tablet

DRUG

Postinor 2

Single dose of 1.5 mg tablet

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
2009-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

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 NCT01073904 on ClinicalTrials.gov