Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | July 2014 |
| End Date: | February 2016 |
| Contact: | Elizabeth I Garner, MD, MPH |
| Email: | egarner@agiletherapeutics.com |
| Phone: | 609-356-1927 |
A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)
Study of the efficacy of a contraceptive patch in 2100 healthy women for up to one year.
AG200-15 is used in a 4-week (28-day) treatment cycle: a patch is applied and replaced every
7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.
7 days for 3 consecutive weeks, followed by a 1-week "patch-free" period.
Inclusion Criteria:
- Healthy, sexually active woman at risk for pregnancy seeking to use hormonal
contraception for at least 1 year
- Ability to demonstrate willingness to participate and adhere to study protocol
Exclusion Criteria:
- Known or suspected pregnancy
- Lactating women
- Anticipates use of condoms or any other form of back-up contraception during the
study
- History of dermal sensitivity to medicated patches (nicotine) or to bandages,
surgical tape, etc.
- Has a contraindication to combined estrogen-progestin contraceptive use
- Any disease that may worsen under hormonal treatment (cardiovascular, liver,
metabolic)
- Smoker who is 35 years old or over
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