Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
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ClinicalTrials.gov Identifier: NCT01181479 |
Recruitment Status
:
Completed
First Posted
: August 13, 2010
Last Update Posted
: February 1, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Contraception | Drug: AG200-15 transdermal patch Drug: Oral Contraceptive | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1504 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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. |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | March 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: AG200-15
Transdermal patch contiaing ethinyl estradiol and levornorgestrel
|
Drug: AG200-15 transdermal patch
Transdermal patch containing ethinyl estradiol and levonorgestrel
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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
|
- Pregnancy [ Time Frame: 1 year ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181479

Study Director: | Marie Foegh, MD, DrSc | Agile Therapeutics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Agile Therapeutics |
ClinicalTrials.gov Identifier: | NCT01181479 History of Changes |
Other Study ID Numbers: |
ATI-CL12 57731 ( Other Identifier: FDA ) |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | February 1, 2013 |
Last Verified: | January 2013 |
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 |