LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Status:	Archived
Conditions:	Contraception
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	January 2011
End Date:	February 2013

Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 Âµg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 Âµg Ethinyl Estradiol and 3 mg Drospirenone (YasminÂ®) in Young Women (18-29 Years) Over 18 Months of Use

The primary objective of this study is to evaluate user satisfaction and tolerability in
young women (18-29 years of age) using the LCS12 compared with young women using a COC
(Yasmin) over a period of 18 months.

Secondary objectives are to observe the tolerability, discontinuation rates, adverse event
profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]),
and bleeding profiles with the two birth-control methods. Additionally, data on missed
tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system
(IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician
satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal
threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of
subjects) will be collected. Finally, in the COC group, information will be collected on the
psychosocial impact of missed or delayed pill intake.

We found this trial at

sites

Clinical Trial Facility

Santa Clara, California 95051

from

Santa Clara, CA