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CompletedNCT01096498LEVEQ-2Updated Jun 11, 2013

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

A Phase 1 interventional study of Levonorgestrel Emergency Pill (BAY86-5028/Opxion) and Levonorgestrel (Postday) in Contraception and Contraception, Postcoital, sponsored by Bayer. Completed at 1 site in Mexico. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-11.

Sponsored by Bayer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Contraception
  • Contraception, Postcoital
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)

  • Active comparator
    Arm 2

    Drug: Levonorgestrel (Postday)

Interventions

  • DrugLevonorgestrel Emergency Pill (BAY86-5028/Opxion)

    Single dose of one 0.75 mg coated tablet

  • DrugLevonorgestrel (Postday)

    Single dose of one 0.75 mg tablet

06

What researchers measure

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

07

Study locations

1 site
  • Morelia, Michoacán 58256, Mexico
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01096498
Lead sponsor
Bayer
First posted
Mar 31, 2010
Start date
Feb 2009
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Jun 11, 2013

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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