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

Contraception Clinical Trial

— ATI-CL13  

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 Containing 150 mcg LNG and 30 mcg EE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236768
• Other study ID #: ATI-CL13
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2010
• Last updated: July 14, 2017
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2017
• Source: Agile Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• AG200-15
Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
• Levora
One tablet of Levora will be taken each day for a 28 day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Agile Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy		6 months