Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System

A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)

Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AG200-15

Detailed Description

AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every 7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.

• Study Type: Interventional
• Enrollment (Actual): 2032
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
• Ability to demonstrate willingness to participate and adhere to study protocol

Exclusion Criteria:

• Known or suspected pregnancy
• Lactating women
• Anticipates use of condoms or any other form of back-up contraception during the study
• History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
• Has a contraindication to combined estrogen-progestin contraceptive use
• Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
• Smoker who is 35 years old or over

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AG200-15; AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)	Drug: AG200-15; Transdermal contraceptive delivery system; Other Names: Transdermal contraceptive delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.	The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset	Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 25 kg/m2, ITT dataset. 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.	1 year
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset	Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 25 and < 30 kg/m2, ITT dataset. 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.	1 year
Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset	Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI ≥ 30 kg/m2, ITT dataset. 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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Skin Irritation at Application Site	Self-reported skin irritation at application site was assessed using the following scoring method: 0: None; Mild; Moderate; Severe	1 year
Self-reported Skin Itching at Application Site	Self-reported skin itching at application site was assessed using the following scoring method: 0: None; Mild; Moderate; Severe	1 year
Self-reported Patch Adhesion	Patch adhesion was reported using the following 5-point scoring method: 0: ≥ 90% adhered (none to minimal lift); ≥ 75% adhered but < 90% (some edges showing lift); ≥ 50% adhered but < 75% (at least half of system lifts off); < 50% (more than half of the patch lifts off, but the patch remains attached); Patch completely detached.	1 year
Cycle Control	Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.	1 year

Collaborators and Investigators

• Sponsor: Agile Therapeutics

Publications and helpful links

General Publications

• Nelson AL, Kaunitz AM, Kroll R, Simon JA, Poindexter AN, Castano PM, Ackerman RT, Flood L, Chiodo JA 3rd, Garner EI; SECURE Investigators. Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results. Contraception. 2021 Mar;103(3):137-143. doi: 10.1016/j.contraception.2020.11.011. Epub 2020 Nov 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: June 4, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: prevention of pregnancy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: ATI-CL23