Clinical trial NCT01422135: Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
Official title: A Pharmacokinetic Study of the Agile TCDS AG200-15 Following Weekly Application to Three Anatomical Sites (Abdomen, Buttock and Upper Torso) in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PK and safety
Pharmacokinetic profile (PK) and safety
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Steady-State Concentration (Css) (48-168) Profile for LNG
timeFrame: 6 weeks
measure: Steady-State Concentration (Css) (48-168) Profile for EE
timeFrame: 6 weeks
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
timeFrame: 6 weeks
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
state: Nebraska
city: Neptune
country: United States
state: New Jersey
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD
role: STUDY_DIRECTOR
References: