Clinical trial NCT01236768: Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Official title: An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraceptive
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-11-09
Enrollment: 407
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy Reported as Pearl Index
timeFrame: 6 months
Secondary outcomes:
measure: Safety
timeFrame: 6 months
Other outcomes:
measure: Cycle Control
timeFrame: 6 months
measure: Irritation and Itching at Application Site
timeFrame: 6 months
measure: Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)
timeFrame: 3 months and 6 months
measure: Adhesion at Application Site
timeFrame: 6 months
Locations:
city: Mobile
country: United States
state: Alabama
city: Green Valley
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: West Hills
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Newburgh
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Las Vegas
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Kernersville
country: United States
state: North Carolina
city: Englewood
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Mount Pleasant
country: United States
state: South Carolina
city: Corpus Christi
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Agile Therapeutics
name: Marie Foegh, MD
role: STUDY_DIRECTOR
References: