LEVEQ-2: Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01096498
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Days): 28
• Patients Per Site Per Month: 26.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Contraception; Contraception, Postcoital	Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion); Drug: Levonorgestrel (Postday)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official 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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion); Single dose of one 0.75 mg coated tablet
Active Comparator: Arm 2	Drug: Levonorgestrel (Postday); Single dose of one 0.75 mg tablet

Outcome Measures

Primary Outcome Measures

1. Least square estimator of average maximum plasmatic concentration (log transformed) [After 2 months]

2. Least square estimator of area under the pharmacokinetic curve (log transformed) [After 2 months]

Secondary Outcome Measures

1. Time at which maximum concentration is reached [After 2 months]

2. Area under the pharmacokinetic curve from time=0 to last blood sample [After 2 months]

3. Half life of plasmatic concentration of study drug [After 2 months]

4. Clearance constant of plasmatic concentration of study drug [After 2 months]

5. Adverse event collection [Up to 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Morelia	Michoacán	Mexico	58256

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01096498
• Other Study ID Numbers: 14355
• First Posted: Mar 31, 2010
• Last Update Posted: Jun 11, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Levonorgestrel

Study Results

No Results Posted as of Jun 11, 2013