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Completed

NCT Number: NCT01375946

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

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AG200-15

Drug

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 names: transdermal contraceptive delivery system, patch

Primary outcomes

  1. Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)

    Time frame: 6 weeks

    AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

  2. AUC(0-168) Profile of Ethinyl Estradiol (EE)

    Time frame: 6 weeks

    AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

  3. Steady-state Concentration (Css) (48-168) Profile of LNG

    Time frame: 6 weeks

    Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

  4. Css (48-168) Profile of EE

    Time frame: 6 weeks

    Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.

Secondary outcomes

  1. Patch Adhesion

    Time frame: 6 weeks

    Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale:

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

    • >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

    Patches were assessed prior to patch removal.

Sponsors and collaborators

Lead sponsor

Agile Therapeutics

Industry

Registry information

Official study title

A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2011
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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