Study to Evaluate the Contraceptive Efficacy/Safety of a... | NCT01181479

NCT01181479

ID	Type	Description	Link
57731	Other Identifier	FDA

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AG200-15 (cycles 1-13)	Experimental	AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.	Drug: AG200-15 (cycles 1-13)
Lessina crossover to AG200-15	Active Comparator	Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.	Drug: Lessina crossover to AG200-15

Name	Type	Description	Arm Group Labels	Other Names
AG200-15 (cycles 1-13)	Drug	AG200-15 containing ethinyl estradiol and levonorgestrel	AG200-15 (cycles 1-13)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy	Pregnancy outcomes was determine by measuring Pearl index. 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.	AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year

Other Outcomes

Measure	Description	Time Frame
Cycle Control	Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.	6 months
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Elizabeth Garner, MD, MPH	Agile Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Agile Investigational Site		Huntsville	Alabama	35801	United States
Agile Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25586864	Derived	Kaunitz AM, Portman D, Westhoff CL, Mishell DR Jr, Archer DF, Foegh M. New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception. 2015 Mar;91(3):211-6. doi: 10.1016/j.contraception.2014.11.013. Epub 2014 Nov 25.
25582984	Derived	Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Foegh M. Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill. Contraception. 2015 Mar;91(3):204-10. doi: 10.1016/j.contraception.2014.11.011. Epub 2014 Nov 25.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AG200-15 (Cycles 1-13)	Intervention with drug: AG200-15 containing ethinyl estradiol and levonorgestrel. Administered for cycles 1-13.
FG001	Lessina (Cycles 1-6)	The Lessina regimen was taken for Cycles 1-6.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.

Arm/Group Information

ID	Title	Description
BG000	AG200-15	Intervention is drug: AG200-15 containing ethinyl estradiol and levonorgestrel for cycles 1-13.
BG001	Lessina Crossover to AG200-15	Intervention with drug: Lessina containing 20 mcg ethinyl estradiol and 100 mcg levonorgestrel in 21 day regimen cycles 1-6 followed by AG200-15 for cycles 7-13.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0005 BG0012 BG0027
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00026.38± 5.663 BG00126.86± 5.738 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001043 BG001230 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0001043 BG001230 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pregnancy

Pregnancy outcomes was determine by measuring Pearl index. 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.

Subjects in the Safety population, age 17-35 with a BMI <32, were analyzed.

Posted

Number

95% Confidence Interval

Pearl Index

AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year

ID	Title	Description
OG000	AG200-15 for Cycle 7-13	Subjects that applied AG200-15 for cycles 7-13.
OG001	Lessina	Subjects that only received Lessina for cycles 1-6.
OG002	AG200-15 for Cycle 1-13	Subjects that applied AG200-15 for all cycles (1-13)

Units	Counts
Participants	OG000675 OG001220 OG002827

Title

Denominators

Categories

Title	Measurements
	OG0005.41(2.35 to 8.46) OG0016.67(0.84 to 12.5) OG0026.43(4.13 to 8.72)

Other Pre-specified

Cycle Control

Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.

Number of subjects with documented cycle information.

Posted

Number

percentage of cycles with BTB/BTS

6 months

ID	Title	Description
OG000	AG200-15 for Cycle 1-6	Subjects that applied AG200-15 for cycles 1-6.
OG001	Lessina	Subjects that only received Lessina for cycles 1-6.

Units	Counts
Participants	OG000

Other Pre-specified

Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)

Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.

Subjects that received contraceptive and were analyzed for LNG and EE.

Posted

Mean

95% Confidence Interval

pg/ml

Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months

ID	Title	Description
OG000	Lessina Cycles 1-6	Subjects that only received Lessina for cycles 1-6.
OG001	AG200-15 for Cycle 1-13	Subjects that applied AG200-15 for cycles 1-13.
OG002	AG200-15 for Cycles 7-13	Subjects switched hormonal contraceptive from Lessina to AG200-15 for cycle 7-13.

Units	Counts
Participants	OG000

Other Pre-specified

Self-reported Irritation at Application Site

Evaluation of irritation at application site was determined using the following scores:

0: None

Mild
Moderate
Severe

Safety Population

Posted

Mean

Standard Deviation

Score on scale

1 year

ID	Title	Description
OG000	All Subjects Who Applied AG200-15	Intervention with drug: AG200-15 containing ethinyl estradiol and levonorgestrel

Units	Counts
Participants	OG0001273

Other Pre-specified

Patch Adhesion by Investigator Evaluation at Each Visit

Evaluation of patch adhesion was determined using the following scores:

0: >= 90% adhered (no lift)

>= 75% adhered but < 90% (some edges showing lift)
>= 50% adhered but < 75% (half of system lifts off)
< 50% (> half of system lifts off, but undetached)
patch completely detached

Safety Population

Posted

Mean

Standard Deviation

Score on a scale

1 year

ID	Title	Description
OG000	All Subjects Who Applied AG200-15	Intervention with drug: AG200-15 containing ethinyl estradiol and levonorgestrel

Units	Counts
Participants	OG000

Other Pre-specified

Self-reported Itching at Patch Application Site

Evaluation of itching at patch application site was determined using the following scores:

0: None

Mild
Moderate
Severe

Safety Population

Posted

Mean

Standard Deviation

Score on a scale

1 year

ID	Title	Description
OG000	All Subjects Who Applied AG200-15	Intervention with drug: AG200-15 containing ethinyl estradiol and levonorgestrel

Units	Counts
Participants	OG0001273

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All AG200-15	All subjects that received AG200-15, including subjects that switched from Lessina to AG200-15 for cycles 7-13.	0	1,273	14	1,273	484	1,273
EG001	Lessina	Subjects that only received Lessina for cycles 1-6.	1	344	4	344	112	344

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Suicidal Ideation	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Head injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected1,273 at risk EG0011 events1 affected344 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected1,273 at risk EG0011 events1 affected344 at risk
Embolism Venous	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Ovarian cyst	Reproductive system and breast disorders	Non-systematic Assessment	EG0002 events2 affected1,273 at risk EG0011 events1 affected344 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Gastointerstinal motility disorder	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Appendicitis	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected1,273 at risk EG0010 events0 affected344 at risk
Calculus urinary	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Liver disorder	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected1,273 at risk EG0011 events1 affected344 at risk
Overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Anaphylactic shock	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk
Gastroenteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected1,273 at risk EG0010 events0 affected344 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG00074 events74 affected1,273 at risk EG00112 events12 affected344 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG00045 events45 affected1,273 at risk EG0019 events9 affected344 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00051 events51 affected1,273 at risk EG0017 events7 affected344 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG00044 events44 affected1,273 at risk EG00111 events11 affected344 at risk
Cervical Dysplasia	Reproductive system and breast disorders	Non-systematic Assessment	EG00080 events80 affected1,273 at risk EG00117 events17 affected344 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG00058 events58 affected1,273 at risk EG00114 events14 affected344 at risk
Human papilloma virus test positive	Investigations	Non-systematic Assessment	EG00040 events40 affected1,273 at risk EG0017 events7 affected344 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG00050 events50 affected1,273 at risk EG00116 events16 affected344 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG00022 events22 affected1,273 at risk EG00110 events10 affected344 at risk
Dysmenorrhea	Reproductive system and breast disorders	Non-systematic Assessment	EG00020 events20 affected1,273 at risk EG0019 events9 affected344 at risk

ID	Term
D057968	Transdermal Patch

Title

Denominators

Categories

Title	Measurements
	OG0001.35± 0.964

Title

Denominators

Categories

Title	Measurements
	OG0001.48± 0.948