Status:
COMPLETED
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
Lead Sponsor:
Agile Therapeutics
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a pharmacokinetics and safety study over 3 weekly applications.
Detailed Description
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
Eligibility Criteria
Inclusion
- Healthy women, ages 18-45 years
- 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
- Known or suspected pregnancy
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01422135
Start Date
February 1 2011
End Date
April 1 2011
Last Update
December 31 2018
Active Locations (2)
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1
Lincoln, Nebraska, United States, 68502
2
Neptune City, New Jersey, United States, 07753