ClinicalTrials.Veeva

Menu

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

Bayer logo

Bayer

Status and phase

Completed
Phase 1

Conditions

Contraception
Contraception, Postcoital

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

24 participants in 2 patient groups

Arm 1
Experimental group
Treatment:
Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
Arm 2
Active Comparator group
Treatment:
Drug: Levonorgestrel (Postday)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems