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AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol

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ClinicalTrials.gov Identifier: NCT01243580
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : December 19, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Ortho-Cyclen
Drug: AG200-15
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AG200-15/Ortho-Cyclen® Ortho-Cyclen®/AG200-15
Hide Arm/Group Description AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol/ 100-120 mcg levonorgestrel per day, was applied weekly for 3 consecutive weeks and was removed on the 4th week for a patch free week. This regimen occurred for Cycles 1 and 2. For cycle 3, Ortho-Cyclen® containing 250 mcg norgestimate and 35 mcg ethinyl estradiol was taken daily for 21 days followed by a drug free interval of 7 days. AG200-15 transdermal contraceptive delivery system, delivering 25-30 mcg ethinyl estradiol and 100-120 mcg levonorgestrel per day, was applied for 3 consecutive weeks and removed on the 4th week for a patch free week. This regimen occurred for Cycle 1 and Cycle 3. Ortho-Cyclen®, containing 250 mcg norgestimate and 35 mcg ethinyl estradiol, was taken daily for 21 days followed by a drug free interval of 7 days for Cycle 2.
Period Title: Overall Study
Started 18 18
Completed 18 16
Not Completed 0 2
Arm/Group Title AG200-15/Ortho-Cyclen® Ortho-Cyclen® /AG200-15 Total
Hide Arm/Group Description Subject applied AG200-15 in cycle 1. Subjects applied AG200-15 (Cycle 2) followed by oral contraceptive, Ortho-Cyclen® (Cycle 3) Subject applied AG200-15 in cycle 1. Subjects received Ortho-Cyclen® (Cycle 2) followed by AG200-15 (Cycle 3). Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
18
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
37.8  (5.85) 36.2  (7.66) 37  (6.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
18
 100.0%
18
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 36 participants
18
 100.0%
18
 100.0%
36
 100.0%
1.Primary Outcome
Title Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1
Hide Description Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of levonorgestrel (LNG) and 25 - 30 mcg EE

Overall Number of Participants Analyzed 29 33
Mean (Standard Deviation)
Unit of Measure: pg/ml
135  (50.7) 45.5  (24.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparing Ortho-Cyclen to Ag200-15
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3
Hide Description Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
131  (45.4) 51.3  (17.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of AG200-15 and Ortho-Cyclen
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1
Hide Description Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 29 32
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
7.28  (2.66) 5.06  (2.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of AG200-15 and Ortho-Cyclen
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3
Hide Description Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
6.97  (2.25) 6.26  (2.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cylen and AG200-15
Statistical Test of Hypothesis P-Value 0.0532
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1
Hide Description Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
43.3  (15.8) 31.4  (15.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cyclen and AG200-15
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3
Hide Description Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
41.5  (13.4) 35.7  (14.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cyclen and AG200-15
Statistical Test of Hypothesis P-Value 0.0167
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Primary Outcome
Title Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1
Hide Description Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
43.3  (15.8) 32.0  (16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cyclen and AG200-15
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Primary Outcome
Title Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3
Hide Description Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
41.5  (13.4) 35.7  (15.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cyclen and AG200-15
Statistical Test of Hypothesis P-Value 0.0175
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Primary Outcome
Title Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1
Hide Description Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
43.3  (15.8) 30.1  (13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cyclen and AG200-15
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Primary Outcome
Title Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3
Hide Description Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description:

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: pg/ml
41.5  (13.4) 37.3  (14.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ortho-Cyclen®, AG200-15
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Comparison of Ortho-Cyclen and AG200-15
Statistical Test of Hypothesis P-Value 0.0532
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Primary Outcome
Title Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3
Hide Description Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title AG200-15
Hide Arm/Group Description:

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: pg/ml
Week 1 1370  (908)
Week 3 2400  (1140)
12.Primary Outcome
Title Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3
Hide Description Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title AG200-15
Hide Arm/Group Description:

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: ng.h/ml
Week 1 160  (88.9)
Week 3 317  (159)
13.Primary Outcome
Title Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3
Hide Description Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary PK population
Arm/Group Title AG200-15
Hide Arm/Group Description:

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: pg/ml
Week 1 1060  (631)
Week 3 1847  (930)
Time Frame 3 months
Adverse Event Reporting Description Adverse events were analyzed based on Organ System class.
 
Arm/Group Title Ortho-Cyclen® AG200-15
Hide Arm/Group Description

Ortho-Cyclen® is a comparator drug intervention

Ortho-Cyclen: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

AG200-15: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

All-Cause Mortality
Ortho-Cyclen® AG200-15
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ortho-Cyclen® AG200-15
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/36 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Ortho-Cyclen® AG200-15
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/34 (8.82%)      23/36 (63.89%)    
Gastrointestinal disorders     
Gastointestinal disorders *  2/34 (5.88%)  2 6/36 (16.67%)  6
General disorders     
General disorders and application site conditions *  1/34 (2.94%)  1 8/36 (22.22%)  8
Infections and infestations     
Infections and infestations *  1/34 (2.94%)  1 3/36 (8.33%)  3
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications *  0/34 (0.00%)  0 1/36 (2.78%)  1
Musculoskeletal and connective tissue disorders     
Muscoloskeletal and conncetive tissue disoders *  0/34 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders     
Nervous system disoders *  0/34 (0.00%)  0 17/36 (47.22%)  17
Reproductive system and breast disorders     
Reproductive system and breast disoders *  0/34 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders *  0/34 (0.00%)  0 1/36 (2.78%)  1
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders *  0/34 (0.00%)  0 2/36 (5.56%)  2
*
Indicates events were collected by non-systematic assessment
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.
Approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL14 study is required prior to publication submission.
Results Point of Contact
Name/Title: Lisa Flood
Organization: Agile Therapeutics
Phone: 609-683-1880
Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01243580     History of Changes
Other Study ID Numbers: ATI-CL14
First Submitted: November 16, 2010
First Posted: November 18, 2010
Results First Submitted: July 21, 2017
Results First Posted: December 19, 2017
Last Update Posted: January 23, 2018