A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT01252186
First received: November 30, 2010
Last updated: February 27, 2015
Last verified: February 2015
Results First Received: February 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Conditions: Hemostasis
Oral Contraceptive
Interventions: Drug: 91-day Levonorgestrel Oral Contraceptive
Drug: 28-day Levonorgestrel Oral Contraceptive
Drug: 28-day Desogestrel Oral Contraceptive

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
91-day Levonorgestrel Oral Contraceptive Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
28-day Levonorgestrel Oral Contraceptive Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
28-day Desogestrel Oral Contraceptive Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.

Participant Flow:   Overall Study
    91-day Levonorgestrel Oral Contraceptive     28-day Levonorgestrel Oral Contraceptive     28-day Desogestrel Oral Contraceptive  
STARTED     87     91     87  
Received Study Drug     83     89     80  
COMPLETED     57     59     53  
NOT COMPLETED     30     32     34  
Adverse Event                 9                 6                 8  
Withdrawal by Subject                 2                 5                 2  
Physician Decision                 0                 0                 1  
Non-compliance                 0                 3                 4  
Protocol Violation                 0                 0                 1  
Pregnancy                 2                 2                 0  
Sponsor Request                 2                 1                 0  
Lost to Follow-up                 10                 10                 11  
Other - Miscellaneous Reasons                 5                 5                 7  



  Baseline Characteristics
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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.
The intent-to-treat (ITT) population included all randomized and treated participants who had both baseline and at least one post-baseline measurement of prothrombin fragment 1+2 (F1+2).

Reporting Groups
  Description
91-day Levonorgestrel Oral Contraceptive Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
28-day Levonorgestrel Oral Contraceptive Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
28-day Desogestrel Oral Contraceptive Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
Total Total of all reporting groups

Baseline Measures
    91-day Levonorgestrel Oral Contraceptive     28-day Levonorgestrel Oral Contraceptive     28-day Desogestrel Oral Contraceptive     Total  
Number of Participants  
[units: participants]
  75     80     71     226  
Age  
[units: years]
Mean (Standard Deviation)
  27.3  (5.87)     26.8  (6.22)     27.0  (5.75)     27.0  (5.94)  
Gender  
[units: participants]
       
Female     75     80     71     226  
Male     0     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
       
Asian     1     5     3     9  
Black or African-American     18     15     9     42  
Caucasian     42     39     40     121  
Hispanic     13     20     19     52  
Other     1     1     0     2  



  Outcome Measures
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1.  Primary:   Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels   [ Time Frame: Baseline to Month 6 ]

2.  Secondary:   Change From Baseline to End of Month 6 in D-dimer   [ Time Frame: Baseline to Month 6 ]

3.  Secondary:   Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex   [ Time Frame: Baseline to Month 6 ]

4.  Secondary:   Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)   [ Time Frame: Baseline to Month 6 ]

5.  Secondary:   Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)   [ Time Frame: Baseline to Month 6 ]

6.  Secondary:   Change From Baseline to End of Month 6 in Fibrinogen   [ Time Frame: Baseline to Month 6 ]

7.  Secondary:   Change From Baseline to End of Month 6 in Plasminogen   [ Time Frame: Baseline to Month 6 ]

8.  Secondary:   Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)   [ Time Frame: Baseline to Month 6 ]

9.  Secondary:   Change From Baseline to End of Month 6 in Factor II   [ Time Frame: Baseline to Month 6 ]

10.  Secondary:   Change From Baseline to End of Month 6 in Factor VII   [ Time Frame: Baseline to Month 6 ]

11.  Secondary:   Change From Baseline to End of Month 6 in Factor VIII   [ Time Frame: Baseline to Month 6 ]

12.  Secondary:   Change From Baseline to End of Month 6 in Antithrombin   [ Time Frame: Baseline to Month 6 ]

13.  Secondary:   Change From Baseline to End of Month 6 in Protein C Activity   [ Time Frame: Baseline to Month 6 ]

14.  Secondary:   Change From Baseline to End of Month 6 in Protein C Antigen   [ Time Frame: Baseline to Month 6 ]

15.  Secondary:   Change From Baseline to End of Month 6 in Free Protein S   [ Time Frame: Baseline to Month 6 ]

16.  Secondary:   Change From Baseline to End of Month 6 in Total Protein S   [ Time Frame: Baseline to Month 6 ]

17.  Secondary:   Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)   [ Time Frame: Baseline to Month 6 ]

18.  Secondary:   Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)   [ Time Frame: Baseline top Month 6 ]

19.  Secondary:   Change From Baseline to End of Month 6 in Total Cortisol   [ Time Frame: Baseline to Month 6 ]

20.  Secondary:   Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin   [ Time Frame: Baseline to Month 6 ]

21.  Secondary:   Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)   [ Time Frame: Baseline to Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Director, Clinical Research
Organization: Teva Branded Pharmaceutical Products, R&D Inc.
phone: 215-591-3000
e-mail: ustevatrials@tevapharm.com



Responsible Party: Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier: NCT01252186     History of Changes
Other Study ID Numbers: PSE-HSP-203
2010-023215-34 ( EudraCT Number )
Study First Received: November 30, 2010
Results First Received: February 27, 2015
Last Updated: February 27, 2015
Health Authority: United States: Food and Drug Administration