Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System

Agile Therapeutics

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Lessina crossover to AG200-15; Drug: AG200-15 (cycles 1-13)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181479

ATI-CL12

57731 (Other Identifier)

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, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Enrollment: 1,504 patients

Sex: Female

Ages: 17 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy females

• 17(in states where the legal age of consent to receive contraceptives is 17)-40 years
• Regular, consistent menstrual cycles between 25 and 35 days
• Sexually active women requesting birth control
• In good general health, confirmed by medical history, physical (including gynecologic) examination and 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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1,504 participants in 2 patient groups

AG200-15 (cycles 1-13)

Experimental group

Description:

AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.

Treatment:

Drug: AG200-15 (cycles 1-13)

Lessina crossover to AG200-15

Active Comparator group

Description:

Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.

Treatment:

Drug: Lessina crossover to AG200-15