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

Agile Therapeutics407 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

407

Conditions

Contraception

Interventions

AG200-15DRUG

Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.

LevoraDRUG

One tablet of Levora will be taken each day for a 28 day cycle.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (21)

Unnamed facility

Mobile, Alabama, United States

Unnamed facility

Green Valley, Arizona, United States

Outcomes

Primary Outcomes

Pregnancy Reported as 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.

Time frame: 6 months

Secondary Outcomes

Safety

Adverse events

Time frame: 6 months

Data from ClinicalTrials.gov

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