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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Contraception Contraception, Postcoital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Levonorgestrel Emergency Pill (BAY86-5028/Opxion)

Intervention Type DRUG

Single dose of 1.5 mg coated tablet

Arm 2

Group Type ACTIVE_COMPARATOR

Levonorgestrel (Postday)

Intervention Type DRUG

Single dose of two 0.75 mg tablets

Interventions

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Levonorgestrel Emergency Pill (BAY86-5028/Opxion)

Single dose of 1.5 mg coated tablet

Intervention Type DRUG

Levonorgestrel (Postday)

Single dose of two 0.75 mg tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes