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
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: AG200-15 (cycles 1-13) Drug: Lessina crossover to AG200-15||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1504 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 Name: 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 Name: hormonal oral contraception and transdermal patch
- Pregnancy [ Time Frame: AG200-15: 6 months; Lessina: 6 months; AG200-15: 1 year ]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.
- Cycle Control [ Time Frame: 6 months ]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.
- Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) [ Time Frame: Lessina: 6 months; AG200-15: 1 year; AG200-15: 6 months ]Measurement of plasma concentrations of LNG and EE for cycles 2, 6 and 13.
- Self-reported Irritation at Application Site [ Time Frame: 1 year ]
Evaluation of irritation at application site was determined using the following scores:
- Patch Adhesion by Investigator Evaluation at Each Visit [ Time Frame: 1 year ]
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
- Self-reported Itching at Patch Application Site [ Time Frame: 1 year ]
Evaluation of itching at patch application site was determined using the following scores:
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:||Elizabeth Garner, MD, MPH||Agile Therapeutics|