Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
NCT ID: NCT01422135
Last Updated: 2018-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2011-02-28
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Abdomen, Buttock, Upper Torso
Patch was placed on abdomen, buttock then the upper torso excluding breast.
Intervention: AG200-15 patch
AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Abdomen, Upper Torso, Buttock
Patch was placed on abdomen, upper torso excluding breast then the buttock.
Intervention: AG200-15 patch
AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Buttock, Abdomen, Upper Torso
Patch was placed on the buttock, abdomen, then the upper torso excluding breast.
Intervention: AG200-15 patch
AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Buttock, Upper Torso, Abdomen,
Patch was placed on the buttock, upper torso excluding breast then the abdomen
Intervention: AG200-15 patch
AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Upper Torso, Abdomen, Buttock
Patch was placed on the upper torso excluding breast, abdomen then buttock.
Intervention: AG200-15 patch
AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Upper Torso, Buttock, Abdomen
Patch was place on the upper torso excluding breast, buttock, then abdomen.
Intervention: AG200-15 patch
AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Interventions
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AG200-15
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index 18 - 32, and weight ≥ 110 lbs.
* Willing to use a non-hormonal method of contraception if of childbearing potential, Or have already undergone previous bilateral tubal ligation or hysterectomy
* Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
* Willing to give informed consent to participate in study
* Hemoglobin within normal range.
Exclusion Criteria
* A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater
* Smoking
* Hypertension (blood pressure \>140 mm Hg systolic and/or \>90 mm Hg diastolic)
* Diabetes Mellitus
* History of headaches with focal neurological symptoms
* Current or history of clinically significant depression in the last year
* Acute or chronic hepatocellular disease with abnormal liver function
* History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
* Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit
18 Years
45 Years
FEMALE
Yes
Sponsors
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Agile Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Garner, MD
Role: STUDY_DIRECTOR
Agile Therapeutics
Locations
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Lincoln, Nebraska, United States
Neptune City, New Jersey, United States
Countries
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Other Identifiers
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ATI-CL15
Identifier Type: -
Identifier Source: org_study_id