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Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions

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ClinicalTrials.gov Identifier: NCT01344369
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : May 30, 2011
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy
Interventions: Drug: Norethindrone/Ethinyl Estradiol
Drug: FEMCON® Fe

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Norethindrone/Ethinyl Estradiol (Test) First 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
FEMCON® Fe (Reference) First 0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Norethindrone/Ethinyl Estradiol (Test) First   FEMCON® Fe (Reference) First
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 

Period 2:   Washout of 28 Days
    Norethindrone/Ethinyl Estradiol (Test) First   FEMCON® Fe (Reference) First
STARTED   18   18 
COMPLETED   17   17 
NOT COMPLETED   1   1 
Withdrawal by Subject                1                0 
Physician Decision                0                1 

Period 3:   Second Intervention
    Norethindrone/Ethinyl Estradiol (Test) First   FEMCON® Fe (Reference) First
STARTED   17   17 
COMPLETED   17   16 
NOT COMPLETED   0   1 
Emesis within 2 x Tmax                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Norethindrone/Ethinyl Estradiol (Test) First 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
FEMCON® Fe (Reference) First 0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
Total Total of all reporting groups

Baseline Measures
   Norethindrone/Ethinyl Estradiol (Test) First   FEMCON® Fe (Reference) First   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   18   18   36 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   18   18   36 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black   12   14   26 
Caucasian   2   1   3 
Hispanic   4   3   7 
Region of Enrollment 
[Units: Participants]
     
United States   18   18   36 


  Outcome Measures

1.  Primary:   Cmax of Norethindrone   [ Time Frame: Blood samples collected over a 60 hour period. ]

2.  Primary:   AUC0-t of Norethindrone   [ Time Frame: Blood samples collected over a 60 hour period. ]

3.  Primary:   AUC0-inf of Norethindrone   [ Time Frame: Blood samples collected over a 60 hour period. ]

4.  Primary:   Cmax of Ethinyl Estradiol   [ Time Frame: Blood samples collected over a 60 hour period. ]

5.  Primary:   AUC0-t of Ethinyl Estradiol   [ Time Frame: Blood samples collected over a 60 hour period. ]

6.  Primary:   AUC0-inf of Ethinyl Estradiol   [ Time Frame: Blood samples collected over a 60 hour period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Associate Director, Biopharmaceutics
Organization: Teva Pharmaceuticals, USA
phone: 1-866-384-5525
e-mail: clinicaltrialqueries@tevausa.com



Responsible Party: Associate Director, Biopharmaceutics, Teva Pharmaceuticals, USA
ClinicalTrials.gov Identifier: NCT01344369     History of Changes
Other Study ID Numbers: 10816221
First Submitted: April 27, 2011
First Posted: April 29, 2011
Results First Submitted: May 4, 2011
Results First Posted: May 30, 2011
Last Update Posted: May 30, 2011