Cross-over Study to Prove Bioequivalence Between Two Oral... | NCT01096485

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

NCT01096485

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 11, 2013Estimated

Enrollment

24Actual

Phase

Phase 1

Conditions

Contraception
Contraception, Postcoital

Interventions

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

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Mar 30, 2010

First Submission Date that Met QC Criteria

Mar 30, 2010

First Posted Date

Mar 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2013

Last Update Posted Date

Jun 11, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
Arm 2	Active Comparator		Drug: Levonorgestrel (Postday)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levonorgestrel Emergency Pill (BAY86-5028/Opxion)	Drug	Single dose of 1.5 mg coated tablet	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Least square estimator of average maximum plasmatic concentration (log transformed)		After 2 months
Least square estimator of area under the pharmacokinetic curve (log transformed)		After 2 months

Secondary Outcomes

Measure	Description	Time Frame
Time at which maximum concentration is reached		After 2 months
Area under the pharmacokinetic curve from time=0 to time of last blood sample		After 2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Morelia	Michoacán	58256	Mexico

Intervention Browse Module

MeSH Terms

ID	Term
D016912	Levonorgestrel

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided