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Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers

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ClinicalTrials.gov Identifier: NCT01375946
Recruitment Status : Completed
First Posted : June 20, 2011
Results First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.

Condition or disease Intervention/treatment Phase
Healthy Drug: AG200-15 Phase 1

Detailed Description:

Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.

There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers
Study Start Date : May 2011
Primary Completion Date : June 2011
Study Completion Date : June 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: AG200-15 location
The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna).
Drug: AG200-15
There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
Other Name: transdermal contraceptive delivery system, patch


Outcome Measures

Primary Outcome Measures :
  1. AUC(0-168) Profile of LNG [ Time Frame: 6 weeks ]
    AUC(0-168) profile of LNG for each external condition.

  2. AUC(0-168) Profile of EE [ Time Frame: 6 weeks ]
    AUC(0-168) profile of EE for each external condition.

  3. Css (48-168) Profile of LNG [ Time Frame: 6 weeks ]
    Css (48-168) profile of LNG for each external condition.

  4. Css (48-168) Profile of EE [ Time Frame: 6 weeks ]
    Css (48-168) profile of EE for each external condition.


Secondary Outcome Measures :
  1. Patch Adhesion [ Time Frame: 6 weeks ]

    Patch adhesion scores by investigator evaluation by external condition using the following scale:

    0: >90% adhered (essentially no lift off of the skin)

    1. >75% adhered but <90% (some edges showing lift)
    2. >50% adhered but <75% (half of system lifts off)
    3. <50% (> half of system lifts off, but undetached)
    4. patch completely detached


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women, ages 18-45
  • Body mass index (BMI)of ≥18 and less than or equal to 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

Exclusion Criteria:

  • Known or suspected pregnancy
  • Breast-feeding or within 1 month after stopping breast-feeding
  • Smokers
  • Any disease that may worsen with hormonal treatment
  • Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
Contacts and Locations

Information from the National Library of Medicine

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): NCT01375946


Locations
United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
Sponsors and Collaborators
Agile Therapeutics
Investigators
Study Director: Elizabeth Garner, MD, MPH Agile Therapeutics
More Information

Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01375946     History of Changes
Other Study ID Numbers: ATI-CL16
First Posted: June 20, 2011    Key Record Dates
Results First Posted: December 21, 2017
Last Update Posted: December 21, 2017
Last Verified: July 2017

Keywords provided by Agile Therapeutics:
Pharmacokinetic Profile (PK) and Safety
PK analysis of EE and LNG