Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System

NCT02158572 | Completed Phase 3 Results

• 1 other identifier: ATI-CL23
• Study Type: interventional
• Target: 2,032
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.

Conditions

Healthy

Keywords

prevention of pregnancy

Outcome Measures

Primary Outcomes (1)

• Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.

  The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. 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.

  1 year

Secondary Outcomes (3)

• Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 25 kg/m2, ITT Dataset

  1 year

• Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 25 and < 30 kg/m2, ITT Dataset

  1 year

• Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI ≥ 30 kg/m2, ITT Dataset

  1 year

Other Outcomes (4)

• Self-reported Skin Irritation at Application Site

  1 year

• Self-reported Skin Itching at Application Site

  1 year

• Self-reported Patch Adhesion

  1 year

Study Arms (1)

AG200-15

EXPERIMENTAL

AG200-15 is a transdermal delivery system designed to deliver daily hormone exposure of ethinyl estradiol (EE) and levonorgestrel (LNG)

Drug: AG200-15

Interventions

AG200-15 DRUG

Transdermal contraceptive delivery system

Also known as: Transdermal contraceptive delivery system

AG200-15

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, sexually active woman at risk for pregnancy seeking to use hormonal contraception for at least 1 year
• Ability to demonstrate willingness to participate and adhere to study protocol

You may not qualify if:

• Known or suspected pregnancy
• Lactating women
• Anticipates use of condoms or any other form of back-up contraception during the study
• History of dermal sensitivity to medicated patches (nicotine) or to bandages, surgical tape, etc.
• Has a contraindication to combined estrogen-progestin contraceptive use
• Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
• Smoker who is 35 years old or over

Sponsors & Collaborators

• Agile Therapeutics: lead

Related Publications (1)

• Nelson AL, Kaunitz AM, Kroll R, Simon JA, Poindexter AN, Castano PM, Ackerman RT, Flood L, Chiodo JA 3rd, Garner EI; SECURE Investigators. Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results. Contraception. 2021 Mar;103(3):137-143. doi: 10.1016/j.contraception.2020.11.011. Epub 2020 Nov 28.

  PMID: 33259782 DERIVED

Results Point of Contact

• Title: Michelle Previtera, Associate Director of Clinical Development
• Organization: Agile Therapeutics

mprevitera@agiletherapeutics.com

609-683-1880

Study Officials

• Elizabeth Garner, MD, MPH

  Agile Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: June 9, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 6, 2020
• Results First Posted: September 25, 2017

Record last verified: 2020-04