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

Phase 1

Completed

• Conditions: Contraception; Contraception, Postcoital
• Interventions: Drug: Levonorgestrel (Postday); Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)

• Registration Number: NCT01096498
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-08
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 2	Levonorgestrel (Postday)	-
Arm 1	Levonorgestrel Emergency Pill (BAY86-5028/Opxion)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time at which maximum concentration is reached	After 2 months
Area under the pharmacokinetic curve from time=0 to last blood sample	After 2 months
Half life of plasmatic concentration of study drug	After 2 months
Clearance constant of plasmatic concentration of study drug	After 2 months
Adverse event collection	Up to 8 weeks