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
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 April 17, 2014