Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm (ATI-CL13)

Agile Therapeutics

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: AG200-15; Drug: Levora

Study type: Interventional

Funder types: Industry

Identifiers

NCT01236768

ATI-CL13

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Full description

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Enrollment: 407 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• sexually active women requesting contraception
• Regular menses every 24 - 35 days
• In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values

Exclusion criteria

• Known or suspected pregnancy
• Lactating women
• Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
• Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
• Use of other contraceptive methods than study medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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407 participants in 2 patient groups

AG200-15

Experimental group

Description:

Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)

Treatment:

Drug: AG200-15

Levora

Active Comparator group

Description:

oral contraceptive containing 150mcg of LNG and 30mcg of EE

Treatment:

Drug: Levora