check_circleStudy Completed
Contraception, Contraception, Postcoital
Bayer Identifier:infoA unique number for a trial given by Bayer.
13956
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Cross-over study to prove bioequivalence between two oral formulations of levonorgestrel
Trial 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.
Key Participants Requirements
Sex
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal info
24The overall number of participants needed for a trial.
Trial Dates info
February 2009 - March 2009Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Levonorgestrel Emergency Pill (BAY86-5028)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
YesA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | Clinica de Enfermedades Cronicas y Procedimientos Especiales | Morelia, 58256, Mexico |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Least square estimator of average maximum plasmatic concentration (log transformed)date_rangeTime Frame:After 2 monthsenhanced_encryptionnoSafety Issue:
- Least square estimator of area under the pharmacokinetic curve (log transformed)date_rangeTime Frame:After 2 monthsenhanced_encryptionnoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Time at which maximum concentration is reacheddate_rangeTime Frame:After 2 monthsenhanced_encryptionnoSafety Issue:
- Area under the pharmacokinetic curve from time=0 to time of last blood sampledate_rangeTime Frame:After 2 monthsenhanced_encryptionnoSafety Issue:
- Clearance constant of plasmatic concentration of study drugdate_rangeTime Frame:After 2 monthsenhanced_encryptionnoSafety Issue:
- Half life of plasmatic concentration of study drugdate_rangeTime Frame:After 2 monthsenhanced_encryptionnoSafety Issue:
- Adverse events collectiondate_rangeTime Frame:Up to 8 weeksenhanced_encryptionyesSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
OtherThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Crossover AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.