A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception



Status:Active, not recruiting
Conditions:Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:16 - 45
Updated:3/13/2019
Start Date:November 2009
End Date:May 2024

Use our guide to learn which trials are right for you!

A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing
intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who
request long-term, reversible contraception for up to 10 years.

This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a
levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include
provision of information to understand efficacy and safety within the widest range of
possible users of the LNG20. Typically, intrauterine contraceptive studies only include women
18-35 years of age for efficacy and safety, and place limits on parity and larger body size.
Women outside of these characteristics also desire an effective intrauterine contraceptive.
Accordingly, this study will include women who are both nulliparous and parous as well as
women less than 18 years of age in the primary efficacy and safety analyses

Inclusion Criteria:

- Healthy women requesting contraception

- 16-35 years old

- Cohort 36-45 years old

- Sexually active

Exclusion Criteria:

- Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy
within 24 months of study entry

- Currently breastfeeding

- Current persistent, abnormal vaginal bleeding
We found this trial at
25
sites
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Vista, CA
Click here to add this to my saved trials