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Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg (LEVEQ-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01073904
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are 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
Contraceptives, Postcoital Drug: Levonorgestrel Emergency Pill (BAY86-5028) Drug: Postinor 2 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Open-label, Randomized, Crossover Study to Prove the Bioequivalence Between Opxion® (Levonorgestrel 1.5 mg Coated Tablet From Bayer de Mexico) and Postinor 2® (Levonorgestrel 1.5 mg Tablet From Biofarma Natural CMD) in Healthy Volunteers
Study Start Date : September 2009
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levonorgestrel Emergency Pill (BAY86-5028)
Single dose of 1.5 mg coated tablet
Active Comparator: Arm 2 Drug: Postinor 2
Single dose of 1.5 mg tablet


Outcome Measures

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 last blood sample [ Time Frame: After 2 months ]
  3. Half life of plasmatic concentration of study drug [ Time Frame: After 2 months ]
  4. Clearance constant of plasmatic concentration of study drug [ Time Frame: After 2 months ]
  5. Adverse events collection [ Time Frame: Up to 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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 tobacco or alcohol abuse 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

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): NCT01073904


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01073904     History of Changes
Other Study ID Numbers: 14782
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

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