Status:
COMPLETED
AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Lead Sponsor:
Agile Therapeutics
Conditions:
Healthy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.
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 followe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01243580
Start Date
August 1 2009
End Date
December 1 2009
Last Update
January 23 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Miami, Florida, United States, 33169