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

Agile Therapeutics

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: AG200-15

Study type: Interventional

Funder types: Industry

Identifiers

NCT02158572

ATI-CL23

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,032 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,032 participants in 1 patient group

AG200-15

Experimental group

Description:

AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)

Treatment:

Drug: AG200-15