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

Purpose

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.

Condition	Intervention	Phase
Contraception	Drug: AG200-15 transdermal patch Drug: Oral Contraceptive	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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.

Resource links provided by NLM:

Drug Information available for: Ethinylestradiol

U.S. FDA Resources

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:

Pregnancy [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Enrollment:	1504
Study Start Date:	August 2010
Study Completion Date:	March 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AG200-15 Transdermal patch contiaing ethinyl estradiol and levornorgestrel	Drug: AG200-15 transdermal patch Transdermal patch containing ethinyl estradiol and levonorgestrel
Active Comparator: Lessina Low dose oral pill containing Ethinyl estardiol and levorgestgrel	Drug: Oral Contraceptive Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen

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).

Eligibility


Ages Eligible for Study:	17 Years to 40 Years (Child, Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181479

Show 80 Study Locations

Sponsors and Collaborators

Agile Therapeutics

Investigators


Study Director:	Marie Foegh, MD, DrSc	Agile Therapeutics

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Agile Therapeutics
ClinicalTrials.gov Identifier:	NCT01181479 History of Changes
Other Study ID Numbers:	ATI-CL12 57731
Study First Received:	August 12, 2010
Last Updated:	January 30, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Agile Therapeutics:


Contraceptive

Additional relevant MeSH terms:


Estradiol Ethinyl Estradiol Contraceptive Agents Contraceptives, Oral Estrogens	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 27, 2016