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

Open-label, Randomized, Parallel Group, Study of Efficacy and Safety of a Transdermal Contraceptive Delivery System (TCDS) in Comparison to a Low-dose Oral Contraceptive Containing 0.02 mg EE and 0.1 mg LNG in a 21-day Regimen.

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: AG200-15 (cycles 1-13); Drug: Lessina crossover to AG200-15

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 1504
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Agile Investigational Site
    • Mobile, Alabama, United States, 36608
      • Agile Investigational Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Agile Investigational Site
    • Green Valley, Arizona, United States, 85614
      • Agile Investigational Site
    • Tucson, Arizona, United States, 85712
      • Agile Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Agile Investigational Site
  • California
    • La Mesa, California, United States, 91942
      • Agile Investigational Site
    • Los Angeles, California, United States, 90057
      • Agile Investigational Site
    • Sacramento, California, United States, 95831
      • Agile Investigational
    • San Diego, California, United States, 92103
      • Agile Investigational Site
    • Santa Ana, California, United States, 92705
      • Agile Investigational Site
    • Vista, California, United States, 92083
      • Agile Investigational Site
    • West Hills, California, United States, 91307
      • Agile Investigational Site
  • Colorado
    • Boulder, Colorado, United States, 80302
      • Agile Investigational Site
    • Colorado Springs, Colorado, United States, 80907
      • Agile Investigational Site
    • Denver, Colorado, United States, 80207
      • Agile Investigational Site
    • Fort Collins, Colorado, United States, 80524
      • Agile Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • Agile Investigational Site
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Agile Investigational Site
    • New London, Connecticut, United States, 06320
      • Agile Investigational Site
    • Waterbury, Connecticut, United States, 06708
      • Agile Investigational Site
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Agile Investigational Site
    • Clearwater, Florida, United States, 33759
      • Agile Investigational Site
    • Daytona Beach, Florida, United States, 32114
      • Agile Investigational Site
    • DeLand, Florida, United States, 32720
      • Agile Investigational Site
    • Fort Myers, Florida, United States, 33916
      • Agile Investigational Site
    • Jacksonville, Florida, United States, 32207
      • Agile Investigational Site
    • Pinellas Park, Florida, United States, 33781
      • Agile Investigational Site
    • Saint Petersburg, Florida, United States, 33709
      • Agile Investigational Site
    • South Miami, Florida, United States, 33143
      • Agile Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • Agile Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Agile Investigational Site
    • Decatur, Georgia, United States, 30034
      • Agile Investigational Site
    • Sandy Springs, Georgia, United States, 30328
      • Agile Investigational Site
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Agile Investigational Site
    • Chicago, Illinois, United States, 60654
      • Agile Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Agile Investigational Site
    • Newburgh, Indiana, United States, 47630
      • Agile Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66202
      • Agile Investigational Site
    • Wichita, Kansas, United States, 67205
      • Agile Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Agile Investigational Site
    • Louisville, Kentucky, United States, 40291
      • Agile Investigational Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Agile Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Agile Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Agile Investigational Site
  • New Jersey
    • Edison, New Jersey, United States, 08817
      • Agile Investigational Site
    • Lawrenceville, New Jersey, United States, 08648
      • Agile Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • Agile Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Agile Investigational Site
    • Charlotte, North Carolina, United States, 28209
      • Agile Investigational Site
    • Kernersville, North Carolina, United States, 27284
      • Agile Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • Agile Investigational Site
    • Salisbury, North Carolina, United States, 28144
      • Agile Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Agile Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Agile Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44311
      • Agile Investigational Site
    • Cincinnati, Ohio, United States, 45267
      • Agile Investigational Site
    • Cleveland, Ohio, United States, 44122
      • Agile Investigational Site
    • Columbus, Ohio, United States, 43213
      • Agile Investigational Site
    • Englewood, Ohio, United States, 45322
      • Agile Investigational Site
    • Mayfield Heights, Ohio, United States, 44124
      • Agile Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Agile Investigational Site
    • Tulsa, Oklahoma, United States, 74105
      • Agile Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Agile Investigational Site
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Agile Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • Agile Investigational Site
    • Memphis, Tennessee, United States, 38120
      • Agile Investigational Site
  • Texas
    • Austin, Texas, United States, 78702
      • Agile Investigational Site
    • Bedford, Texas, United States, 76022
      • Agile Investigational Site
    • Corpus Christi, Texas, United States, 78414
      • Agile Investigational Site
    • Dallas, Texas, United States, 75231
      • Agile Investigational Site
    • Houston, Texas, United States, 77089
      • Agile Investigational Site
    • San Antonio, Texas, United States, 78229
      • Agile Investigational Site
    • Sugar Land, Texas, United States, 77479
      • Agile Investigational Site
    • Webster, Texas, United States, 77598
      • Agile Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • Agile Investigational Site
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Agile Investigational Site
    • Norfolk, Virginia, United States, 23502
      • Agile Investigational Site
    • Richmond, Virginia, United States, 23294
      • Agile Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Agile Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AG200-15 (cycles 1-13); AG200-15 containing ethinyl estradiol and levonorgestrel. Type of intervention is drug.	Drug: AG200-15 (cycles 1-13); AG200-15 containing ethinyl estradiol and levonorgestrel; Other Names: transdermal patch
Active Comparator: Lessina crossover to AG200-15; Lessina containing ethinyl estradiol and levonorgestrel for 6 cycles followed by AG200-15 for 6 cycles. Type of intervention is drug.	Drug: Lessina crossover to AG200-15; Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.; Other Names: hormonal oral contraception and transdermal patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	Pregnancy outcomes was determine by measuring 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.	AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycle Control	Measuring the breakthrough bleeding (BTB) and/or breakthrough spotting (BTS). Measured as a percent of total number of cycles in each Arm/Group with BTB and/or BTS.	6 months
Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)	Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.	Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months
Self-reported Irritation at Application Site	Evaluation of irritation at application site was determined using the following scores: 0: None; Mild; Moderate; Severe	1 year
Patch Adhesion by Investigator Evaluation at Each Visit	Evaluation of patch adhesion was determined using the following scores: 0: >= 90% adhered (no lift); >= 75% adhered but < 90% (some edges showing lift); >= 50% adhered but < 75% (half of system lifts off); < 50% (> half of system lifts off, but undetached); patch completely detached	1 year
Self-reported Itching at Patch Application Site	Evaluation of itching at patch application site was determined using the following scores: 0: None; Mild; Moderate; Severe	1 year

Collaborators and Investigators

• Sponsor: Agile Therapeutics

Publications and helpful links

General Publications

• Kaunitz AM, Portman D, Westhoff CL, Mishell DR Jr, Archer DF, Foegh M. New contraceptive patch wearability assessed by investigators and participants in a randomized phase 3 study. Contraception. 2015 Mar;91(3):211-6. doi: 10.1016/j.contraception.2014.11.013. Epub 2014 Nov 25.
• Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Foegh M. Self-reported and verified compliance in a phase 3 clinical trial of a novel low-dose contraceptive patch and pill. Contraception. 2015 Mar;91(3):204-10. doi: 10.1016/j.contraception.2014.11.011. Epub 2014 Nov 25.
• Kaunitz AM, Portman D, Westhoff CL, Archer DF, Mishell DR Jr, Rubin A, Foegh M. Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):295-303. doi: 10.1097/AOG.0000000000000095.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Contraceptive
• Other Study ID Numbers: ATI-CL12; 57731 (Other Identifier: FDA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No