Trial Outcomes & Findings for Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm (NCT NCT01236768)

NCT ID: NCT01236768

Last Updated: 2017-09-15

Results Overview

Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 407 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-09-15

Participant Flow

Participant milestones

Measure	AG200-15 Transdermal contraceptive delivery system (TCDS)	Levora hormonal oral contraceptive
Overall Study STARTED	201	206
Overall Study COMPLETED	112	145
Overall Study NOT COMPLETED	89	61

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	AG200-15 n=177 Participants 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 n=188 Participants hormonal oral contraceptive	Total n=365 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	177 Participants n=5 Participants	188 Participants n=7 Participants	365 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants	188 Participants n=7 Participants	365 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	177 Participants n=5 Participants	188 Participants n=7 Participants	365 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intent-to-treat population ages 18-35.

Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.

Outcome measures

Measure	AG200-15 n=147 Participants 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 n=163 Participants hormonal oral contraceptive
Pregnancy Reported as Pearl Index	8.19 Pearl Index Interval 0.19 to 16.19	6.80 Pearl Index Interval 0.15 to 13.44

SECONDARY outcome

Timeframe: 6 months

Population: Any subject who applied a patch.

Adverse events

Outcome measures

Measure	AG200-15 n=177 Participants 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 n=188 Participants hormonal oral contraceptive
Safety	85 Events	88 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle.

The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.

Outcome measures

Measure	AG200-15 n=162 Participants 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 n=182 Participants hormonal oral contraceptive
Cycle Control	24.5 percent cycles with BTB or BTS	21 percent cycles with BTB or BTS

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Subject self-reported worse irritation score in a cycle.

AG200-15 irritation and itching scores are defined as follows:

0=none

1. mild

2. moderate

3. severe

Outcome measures

Measure	AG200-15 n=170 Participants 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
Irritation and Itching at Application Site Irritation Score (cycles 1-6 combined)	1.15 Score Standard Deviation 0.914	—
Irritation and Itching at Application Site Itching Score (cycles 1-6 combined)	1.31 Score Standard Deviation 0.851	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months and 6 months

Population: Number of subjects with available LNG data for cycle 3 or cycle 6

Measurement of plasma levels of levonorgestrel and ethinyl estradiol.

Outcome measures

Measure	AG200-15 n=111 Participants 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 n=140 Participants hormonal oral contraceptive
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) LNG cycle 3	2244 pg/mL Interval 1887.0 to 2600.0	3474 pg/mL Interval 3044.0 to 3904.0
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) LNG cycle 6	1743 pg/mL Interval 1478.0 to 2007.0	3682 pg/mL Interval 3136.0 to 4228.0
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) EE cycle 3	44.5 pg/mL Interval 38.7 to 50.3	50.6 pg/mL Interval 43.0 to 58.3
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) EE cycle 6	34.7 pg/mL Interval 30.1 to 39.4	54.7 pg/mL Interval 44.8 to 64.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Population: Subjects that have documented adhesion scores.

Measurement of adhesion of application site is defined as follows:

0: >=90% adhered (no lifting)

1. >=75% adhered but <90% (some edges showing lifting)

2. >=50% adhered but <75% (half of the patch lifts off)

3. <50% (> half of patch lifts off, but not detached)

4. patch completely detached

Outcome measures

Measure	AG200-15 n=159 Participants 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
Adhesion at Application Site	0.46 Score Standard Deviation 1.118	—

Adverse Events

AG200-15

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Levora

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	AG200-15 n=177 participants at risk 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 n=188 participants at risk oral contraceptive containing 150mcg of LNG and 30mcg of EE Levora: One tablet of Levora will be taken each day for a 28 day cycle.
Infections and infestations Murine Typhus	0.00% 0/177 • 6 months	0.53% 1/188 • Number of events 1 • 6 months
Nervous system disorders Convulsion	0.00% 0/177 • 6 months	0.53% 1/188 • Number of events 1 • 6 months

Other adverse events

Measure	AG200-15 n=177 participants at risk 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 n=188 participants at risk oral contraceptive containing 150mcg of LNG and 30mcg of EE Levora: One tablet of Levora will be taken each day for a 28 day cycle.
Gastrointestinal disorders Nausea	2.8% 5/177 • Number of events 5 • 6 months	5.9% 11/188 • Number of events 11 • 6 months
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	2.3% 4/177 • Number of events 4 • 6 months	4.3% 8/188 • Number of events 8 • 6 months
Infections and infestations Sinusitis	4.0% 7/177 • Number of events 7 • 6 months	2.7% 5/188 • Number of events 5 • 6 months
Reproductive system and breast disorders Cervical dysplasia	5.6% 10/177 • Number of events 10 • 6 months	5.9% 11/188 • Number of events 11 • 6 months
Infections and infestations Nasopharyngitis	5.1% 9/177 • Number of events 9 • 6 months	4.3% 8/188 • Number of events 8 • 6 months
Respiratory, thoracic and mediastinal disorders Sinus Congestion	4.0% 7/177 • Number of events 7 • 6 months	1.1% 2/188 • Number of events 2 • 6 months

Additional Information

Lisa Flood, Associate Director of Clinical Operations

Agile Therapeutics

Phone: 609-683-1880

Email: lflood@agiletherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Review and approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL13 study is required prior to publication submission.
• Publication restrictions are in place

Restriction type: OTHER