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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel (LEVEQ-1)

This study has been completed.
Information provided by:
Bayer Identifier:
First received: March 30, 2010
Last updated: June 9, 2013
Last verified: June 2013
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.

Condition Intervention Phase
Contraception, Postcoital
Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
Drug: Levonorgestrel (Postday)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Open-label, Randomized, Crossover Study to Compare the Bioavailability of One Coated Tablet of Opxion® (Levonorgestrel 1.5 mg From Bayer de Mexico) vs. Two Tablets of Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time at which maximum concentration is reached [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Area under the pharmacokinetic curve from time=0 to time of last blood sample [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Clearance constant of plasmatic concentration of study drug [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Half life of plasmatic concentration of study drug [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
Single dose of 1.5 mg coated tablet
Active Comparator: Arm 2 Drug: Levonorgestrel (Postday)
Single dose of two 0.75 mg tablets


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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01096485

Morelia, Michoacán, Mexico, 58256
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Medical Director, Bayer de Mexico S.A. de C.V. Identifier: NCT01096485     History of Changes
Other Study ID Numbers: 13956 
Study First Received: March 30, 2010
Last Updated: June 9, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Additional relevant MeSH terms:
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on December 09, 2016