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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01096485
First received: March 30, 2010
Last updated: June 9, 2013
Last verified: June 2013
  Purpose
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
Contraception, Postcoital
Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
Drug: Levonorgestrel (Postday)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]
  • Least square estimator of area under the pharmacokinetic curve (log transformed) [ Time Frame: After 2 months ]

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

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

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096485

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

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
Study First Received: March 30, 2010
Last Updated: June 9, 2013

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

ClinicalTrials.gov processed this record on March 29, 2017