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Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01422135
First received: August 19, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

This is a pharmacokinetics and safety study over 3 weekly applications.


Condition Intervention Phase
Healthy
Drug: AG200-15
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • Pharmacokinetic profile of LNG and EE [ Time Frame: Sampling will occur at 0 hour, 3, 6, 12, 24, 48, 72, 120, 144, 168 hours and after patch removal at 174, 180, 192, 216, 240 hours. ] [ Designated as safety issue: No ]

    Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK results will be reported in pg/mL.

    Log-transformed PK parameters (AUCs Cmax and Css) will be analyzed with an analysis of variance (ANOVA) model.



Secondary Outcome Measures:
  • Patch adhesion [ Time Frame: 168 hour timepoint ] [ Designated as safety issue: No ]
    Adhesion assessed immediately prior to patch removal

  • Safety [ Time Frame: Adverse Events will be collected from first dose through 30 days post-dosing ] [ Designated as safety issue: Yes ]
    Safety evaluations are based on the number of discontinuations due to Adverse Events, changes in physical and gynecological examination, and treatment-emergent changes in vital signs and body weight.


Enrollment: 24
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AG200-15
Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts.
Drug: AG200-15
A transdermal contraceptive delivery system for LNG and 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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422135

Locations
United States, Nebraska
Lincoln, Nebraska, United States, 68502
United States, New Jersey
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Agile Therapeutics
Investigators
Study Director: Marie Foegh, MD Agile Therapeutics
  More Information

No publications provided

Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01422135     History of Changes
Other Study ID Numbers: ATI-CL15
Study First Received: August 19, 2011
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Agile Therapeutics:
PK and safety
Pharmacokinetic profile (PK) and safety

ClinicalTrials.gov processed this record on November 27, 2014