DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Agile Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Ortho-Cyclen (r) (Drug); AG200-15 containing LNG and EE (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Agile Therapeutics

Official(s) and/or principal investigator(s):
Marie Foegh, MD, Study Director, Affiliation: Agile Therapeutics

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Comparative evaluation of EE pharmacokinetics between AG200-15 and Ortho-Cyclen®

Secondary outcome: 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

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Miami, Florida 33169, United States
Additional Information

Starting date: August 2009
Last updated: December 2, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017