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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01096498
First received: March 30, 2010
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

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 last blood sample [ 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 ]
  • Clearance constant of plasmatic concentration of study drug [ Time Frame: After 2 months ] [ Designated as safety issue: No ]
  • Adverse event 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 one 0.75 mg coated tablet
Active Comparator: Arm 2 Drug: Levonorgestrel (Postday)
Single dose of one 0.75 mg tablet

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096498

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer de Mexico S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01096498     History of Changes
Other Study ID Numbers: 14355
Study First Received: March 30, 2010
Last Updated: June 14, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

ClinicalTrials.gov processed this record on May 23, 2013