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OpenTrials
Completed

NCT Number: NCT01096498

Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

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.

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Key information

Conditions

Contraception Contraception, Postcoital

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Morelia, Michoacán, 58256, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levonorgestrel Emergency Pill (BAY86-5028/Opxion)

Drug

Single dose of one 0.75 mg coated tablet

Levonorgestrel (Postday)

Drug

Single dose of one 0.75 mg tablet

Primary outcomes

  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 outcomes

  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 event collection

    Time frame: Up to 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: LEVEQ-2

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 31, 2010
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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