- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096498
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel (LEVEQ-2)
June 8, 2013 updated by: Bayer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michoacán
-
Morelia, Michoacán, Mexico, 58256
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 2
|
Single dose of one 0.75 mg tablet
|
Experimental: Arm 1
|
Single dose of one 0.75 mg coated tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Least square estimator of average maximum plasmatic concentration (log transformed)
Time Frame: After 2 months
|
After 2 months
|
Least square estimator of area under the pharmacokinetic curve (log transformed)
Time Frame: After 2 months
|
After 2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time at which maximum concentration is reached
Time Frame: After 2 months
|
After 2 months
|
Area under the pharmacokinetic curve from time=0 to last blood sample
Time Frame: After 2 months
|
After 2 months
|
Half life of plasmatic concentration of study drug
Time Frame: After 2 months
|
After 2 months
|
Clearance constant of plasmatic concentration of study drug
Time Frame: After 2 months
|
After 2 months
|
Adverse event collection
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 30, 2010
First Submitted That Met QC Criteria
March 30, 2010
First Posted (Estimate)
March 31, 2010
Study Record Updates
Last Update Posted (Estimate)
June 11, 2013
Last Update Submitted That Met QC Criteria
June 8, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contraception
-
Virginia Commonwealth UniversityCompletedPregnancy Related | Contraception | Contraception Behavior | Contraception Use
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
Janssen Pharmaceutica N.V., BelgiumCompleted
-
Medical University of South CarolinaSociety of Family PlanningCompletedContraception | Contraception BehaviorUnited States
-
Teva Branded Pharmaceutical Products R&D, Inc.CompletedFemale Contraception | ContraceptionUnited States, Israel
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...CompletedFemale Contraception | Contraception
-
University of California, San FranciscoAgency for Healthcare Research and Quality (AHRQ); Essential Access HealthNot yet recruitingContraception | Contraception Behavior | Reproductive BehaviorUnited States
Clinical Trials on Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
-
BayerCompletedContraception | Contraception, PostcoitalMexico
-
BayerCompletedContraceptionSweden, Finland, Hungary, Norway, United Kingdom
-
BayerCompletedContraceptives, PostcoitalMexico
-
BayerCompletedContraceptionBelgium, United States, Russian Federation, Germany, Austria
-
BayerCompletedContraceptionBelgium, Sweden, Austria, Finland, Netherlands, Germany, Denmark, Norway
-
BayerCompleted
-
BayerCompletedMenorrhagia, DysmenorrheaJapan
-
BayerCompletedContraceptionChina, Korea, Republic of, Australia
-
BayerCompleted
-
BayerCompletedIdiopathic MenorrhagiaCroatia, Saudi Arabia, Bulgaria, Jordan, Romania, Russian Federation, Turkey, United Arab Emirates, Kuwait, India, Pakistan, Serbia, Sri Lanka