Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel (LEVEQ-2)

Open-label, Randomized, Crossover Study to Prove Bioequivalence Between Opxion® (Levonorgestrel 0.75 mg From Bayer de Mexico) and Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Contraception, Postcoital
• Intervention / Treatment: Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion); Drug: Levonorgestrel (Postday)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Michoacán
    • Morelia, Michoacán, Mexico, 58256

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Levonorgestrel (Postday); Single dose of one 0.75 mg tablet
Experimental: Arm 1	Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion); Single dose of one 0.75 mg coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: March 30, 2010
• First Posted (Estimate): March 31, 2010

Study Record Updates

• Last Update Posted (Estimate): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 8, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: 14355