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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01243580

Run by

Agile Therapeutics

People needed

36

Starts

2009-08-01

Expected to finish

2009-12-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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