Trial Outcomes & Findings for Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches (NCT NCT01623466)

NCT ID: NCT01623466

Last Updated: 2018-01-23

Results Overview

The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-01-23

Participant Flow

Participant milestones

Measure	AG890-6.5 Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Overall Study STARTED	18	18
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches

Baseline characteristics by cohort

Measure	AG890-6.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	29.83 years STANDARD_DEVIATION 8.473 • n=93 Participants	34.94 years STANDARD_DEVIATION 6.673 • n=4 Participants	32.39 years STANDARD_DEVIATION 7.951 • n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	18 Participants n=93 Participants	18 Participants n=4 Participants	36 Participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Primary PK population

The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.

Outcome measures

Measure	AG890-6.5 n=17 Participants Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Levonorgestrel Pharmacokinetic Profile	100 % of subjects below 175 pg/mL	83.3 % of subjects below 175 pg/mL

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety population

Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale:

0: ≥90% adhered (no lift)

1. ≥75% adhered but <90% (some edges showing lift)

2. ≥50% adhered but <75% (half of system lifts off)

3. <50% (< half of system lifts off, but undetached)

4. patch completely detached

Outcome measures

Measure	AG890-6.5 n=17 Participants Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Evaluation of Patch Adhesion	0.41 Score on a scale Standard Deviation 1.004	0.78 Score on a scale Standard Deviation 1.517

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety population

Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale:

0: None

1. Mild

2. Moderate

3. Severe

Outcome measures

Measure	AG890-6.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Evaluation of Irritation at Patch Application Site	0.11 Score on a scale Standard Deviation 0.471	0.06 Score on a scale Standard Deviation 0.236

PRIMARY outcome

Timeframe: 8 weeks

Population: Safety Population

Self-reported worst skin itching at patch application site by subject using a 4-point scale:

0. None

1. Mild

2. Moderate

3. Severe

Outcome measures

Measure	AG890-6.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Evaluation of Itching at Patch Application Site	0.33 Score Standard Deviation 0.594	0.39 Score Standard Deviation 0.502

PRIMARY outcome

Timeframe: 8 weeks

Population: Completed subjects

Measurement of unscheduled bleeding/spotting days.

Outcome measures

Measure	AG890-6.5 n=17 Participants Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 Participants Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Cycle Control	8.4 days Standard Deviation 4.81	8.3 days Standard Deviation 4.23

Adverse Events

AG890-6.5

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

AG890-12.5

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AG890-6.5 n=18 participants at risk Evaluate levonorgestrel delivery in AG890-6.5 levonorgestrel: transdermal contraceptive delivery system	AG890-12.5 n=18 participants at risk Evaluate levonorgestrel delivery in AG890-12.5 levonorgestrel: transdermal contraceptive delivery system
Gastrointestinal disorders Gastrointestinal Disorders	5.6% 1/18 • Number of events 1	5.6% 1/18 • Number of events 2
Immune system disorders Immune system disorders	5.6% 1/18 • Number of events 1	0.00% 0/18
Metabolism and nutrition disorders Metabolism and nutrition disorders	11.1% 2/18 • Number of events 2	11.1% 2/18 • Number of events 2
Nervous system disorders Nervous system disorders	50.0% 9/18 • Number of events 9	27.8% 5/18 • Number of events 5
Psychiatric disorders Psychiatric disorders	5.6% 1/18 • Number of events 1	11.1% 2/18 • Number of events 2
Reproductive system and breast disorders Reproductive system ad breast disorders	16.7% 3/18 • Number of events 3	27.8% 5/18 • Number of events 5
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	5.6% 1/18 • Number of events 1	0.00% 0/18

Additional Information

Lisa Flood

Agile Therapeutics

Phone: 609-683-1880

Email: lflood@agiletherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee All publications must be reviewed and approved by sponsor
• Publication restrictions are in place

Restriction type: OTHER