Trial Outcomes & Findings for Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females (NCT NCT01422135)
NCT ID: NCT01422135
Last Updated: 2018-12-31
Results Overview
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-12-31
Participant Flow
Participant milestones
| Measure |
Lower Abdomen, Buttock, Upper Torso Excluding Breast
Subjects applied AG200-15 to Abdomen, Buttock, then Upper Torso excluding Breast
|
Lower Abdomen, Upper Torso Excluding Breast, Buttock
Subjects applied AG200-15 to Abdomen, Upper Torso excluding Breast, then Buttock
|
Buttock, Lower Abdomen, Upper Torso Excluding Breast
Subjects applied AG200-15 to Buttock, Abdomen, then Upper Torso excluding Breast
|
Buttock, Upper Torso Excluding Breast, Lower Abdomen
Subjects applied AG200-15 to Buttock, Upper Torso excluding Breast, then Lower Abdomen.
|
Upper Torso Excluding Breast, Lower Abdomen, Buttock
Subjects applied AG200-15 to Upper Torso excluding Breast, Lower Abdomen, then Buttock
|
Upper Torso Excluding Breast, Buttock, Lower Abdomen
Subjects applied AG200-15 to Upper Torso excluding Breast, Buttock, then Lower Abdomen
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
3
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
Baseline characteristics by cohort
| Measure |
AG200-15
n=24 Participants
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 8.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Primary PK population
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Outcome measures
| Measure |
AG200-15
n=22 Participants
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
|---|---|
|
Steady-State Concentration (Css) (48-168) Profile for LNG
Abdomen
|
1256 pg/mL
Standard Deviation 998
|
|
Steady-State Concentration (Css) (48-168) Profile for LNG
Buttock
|
1246 pg/mL
Standard Deviation 725
|
|
Steady-State Concentration (Css) (48-168) Profile for LNG
Upper torso
|
1384 pg/mL
Standard Deviation 728
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Primary PK population
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Outcome measures
| Measure |
AG200-15
n=22 Participants
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
|---|---|
|
Steady-State Concentration (Css) (48-168) Profile for EE
Abdomen
|
35.8 pg/mL
Standard Deviation 19.9
|
|
Steady-State Concentration (Css) (48-168) Profile for EE
Buttock
|
40.7 pg/mL
Standard Deviation 16.4
|
|
Steady-State Concentration (Css) (48-168) Profile for EE
Upper torso
|
42.3 pg/mL
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Primary PK population
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Outcome measures
| Measure |
AG200-15
n=22 Participants
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
Abdomen
|
182 ng*hr/mL
Standard Deviation 135
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
Buttock
|
197 ng*hr/mL
Standard Deviation 116
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
Upper torso
|
206 ng*hr/mL
Standard Deviation 106
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Primary PK population
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Outcome measures
| Measure |
AG200-15
n=22 Participants
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
Abdomen
|
5.8 ng*hr/mL
Standard Deviation 2.8
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
Buttock
|
7.12 ng*hr/mL
Standard Deviation 2.85
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
Upper torso
|
6.86 ng*hr/mL
Standard Deviation 2.53
|
Adverse Events
AG200-15 on Lower Abdomen
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
AG200-15 on Buttock
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
AG200-15 on Upper Torso Excluding Breast
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AG200-15 on Lower Abdomen
n=22 participants at risk
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
AG200-15 on Buttock
n=23 participants at risk
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
AG200-15 on Upper Torso Excluding Breast
n=23 participants at risk
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
27.3%
6/22 • Number of events 6 • 6 weeks
|
52.2%
12/23 • Number of events 12 • 6 weeks
|
43.5%
10/23 • Number of events 10 • 6 weeks
|
|
General disorders
General disorders and adminstration site conditions
|
31.8%
7/22 • Number of events 7 • 6 weeks
|
30.4%
7/23 • Number of events 7 • 6 weeks
|
56.5%
13/23 • Number of events 13 • 6 weeks
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
9.1%
2/22 • Number of events 2 • 6 weeks
|
8.7%
2/23 • Number of events 2 • 6 weeks
|
0.00%
0/23 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
8.7%
2/23 • Number of events 2 • 6 weeks
|
8.7%
2/23 • Number of events 2 • 6 weeks
|
|
Nervous system disorders
Nervous system disorders
|
36.4%
8/22 • Number of events 8 • 6 weeks
|
47.8%
11/23 • Number of events 11 • 6 weeks
|
30.4%
7/23 • Number of events 7 • 6 weeks
|
|
Psychiatric disorders
Psychiatric disorders
|
13.6%
3/22 • Number of events 3 • 6 weeks
|
13.0%
3/23 • Number of events 3 • 6 weeks
|
4.3%
1/23 • Number of events 1 • 6 weeks
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
40.9%
9/22 • Number of events 9 • 6 weeks
|
56.5%
13/23 • Number of events 13 • 6 weeks
|
43.5%
10/23 • Number of events 10 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
9.1%
2/22 • Number of events 2 • 6 weeks
|
0.00%
0/23 • 6 weeks
|
4.3%
1/23 • Number of events 1 • 6 weeks
|
|
Vascular disorders
Vascular disorders
|
4.5%
1/22 • Number of events 1 • 6 weeks
|
4.3%
1/23 • Number of events 1 • 6 weeks
|
0.00%
0/23 • 6 weeks
|
Additional Information
Joseph Chiodo III, Senior Medical Director
Agile Therapeutics
Phone: 609-683-1880
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL15 study is required prior to publication submission.
- Publication restrictions are in place
Restriction type: OTHER