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Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm (ATI-CL13)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236768
First Posted: November 9, 2010
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Agile Therapeutics
Results First Submitted: July 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Contraception
Interventions: Drug: AG200-15
Drug: Levora

  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
AG200-15 Transdermal contraceptive delivery system (TCDS)
Levora hormonal oral contraceptive

Participant Flow:   Overall Study
    AG200-15   Levora
STARTED   201   206 
COMPLETED   112   145 
NOT COMPLETED   89   61 



  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.
Safety Population (number of subjects that received drug)

Reporting Groups
  Description
AG200-15

Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)

AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.

Levora hormonal oral contraceptive
Total Total of all reporting groups

Baseline Measures
   AG200-15   Levora   Total 
Overall Participants Analyzed 
[Units: Participants]
 177   188   365 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      177 100.0%      188 100.0%      365 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      177 100.0%      188 100.0%      365 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   177   188   365 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pregnancy Reported as Pearl Index   [ Time Frame: 6 months ]

2.  Secondary:   Safety   [ Time Frame: 6 months ]

3.  Other Pre-specified:   Cycle Control   [ Time Frame: 6 months ]

4.  Other Pre-specified:   Irritation and Itching at Application Site   [ Time Frame: 6 months ]

5.  Other Pre-specified:   Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)   [ Time Frame: 3 months and 6 months ]

6.  Other Pre-specified:   Adhesion at Application Site   [ Time Frame: 6 months ]


  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: Lisa Flood, Associate Director of Clinical Operations
Organization: Agile Therapeutics
phone: 609-683-1880
e-mail: lflood@agiletherapeutics.com



Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01236768     History of Changes
Other Study ID Numbers: ATI-CL13
First Submitted: November 5, 2010
First Posted: November 9, 2010
Results First Submitted: July 20, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017