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AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol

This study has been completed.
Sponsor:
Information provided by:
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01243580
First received: November 16, 2010
Last updated: December 2, 2010
Last verified: November 2010
History of Changes
  Purpose

Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.


Condition Intervention Phase
Healthy
 Drug: Ortho-Cyclen (r)
Drug: AG200-15 containing LNG and EE
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate Pharmacokinetic Profile of Agile TCDS AG200-15 and to Compare Exposure to Ethinyl Estradiol to Oral Contraceptive (Orthocyclen®) in Healthy Female Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • Comparative evaluation of EE pharmacokinetics between AG200-15 and Ortho-Cyclen® [ Time Frame: 0,6,12,24,48,72,120,144,168 hours post patch; 0.5, 1,1.5,3,6,9,12,16&24 hours post Ortho-Cyclen dosing ] [ Designated as safety issue: No ]
    Log-transformed PK parameters (AUCs, Cmax and Css) will be analyzed with an analysis of variance (ANOVA) model.


Secondary Outcome Measures:
  • Safety of AG200-15 including study discontinuation information, changes in physical and GYN exam findings, changes in vital signs, body weight & lab results & all Adverse Events will be summarized [ Time Frame: Adverse Events will be collected from first dose through 30 days post-dosing ] [ Designated as safety issue: Yes ]
    Safety of AG200-15 over two consecutive cycles of therapy will be evaluated.


Enrollment: 36
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ortho-Cyclen®
comparator
 Drug: Ortho-Cyclen (r)
an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.
Other Name: oral contraceptive
Experimental: AG200-15
investigational transdermal contraceptive delivery system
 Drug: AG200-15 containing LNG and EE
transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
Other Name: transdermal contraception

Detailed Description:

This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).

Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).

  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
  • Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.
  • Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy
  • Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period

Exclusion Criteria:

  • Known or suspected pregnancy;
  • Lactating women
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication
  • Smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243580

Locations
United States, Florida
Miami, Florida, United States, 33169
Sponsors and Collaborators
Agile Therapeutics
Investigators
Study Director: Marie Foegh, MD Agile Therapeutics
  More Information

No publications provided by Agile Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lisa Flood, Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01243580     History of Changes
Other Study ID Numbers: ATI-CL14
Study First Received: November 16, 2010
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Estradiol
Ethinyl Estradiol
Moxifloxacin
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Infective Agents
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on May 23, 2013