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

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ClinicalTrials.gov Identifier: NCT01096485
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : June 11, 2013
Sponsor:
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Least square estimator of average maximum plasmatic concentration (log transformed) [ Time Frame: After 2 months ]
  2. Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After 2 months ]

Secondary Outcome Measures :
  1. Time at which maximum concentration is reached [ Time Frame: After 2 months ]
  2. Area under the pharmacokinetic curve from time=0 to time of last blood sample [ Time Frame: After 2 months ]
  3. Clearance constant of plasmatic concentration of study drug [ Time Frame: After 2 months ]
  4. Half life of plasmatic concentration of study drug [ Time Frame: After 2 months ]
  5. Adverse events collection [ Time Frame: Up to 8 weeks ]


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096485


Locations
Mexico
Morelia, Michoacán, Mexico, 58256
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer de Mexico S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01096485     History of Changes
Other Study ID Numbers: 13956
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral