LCS16 vs. COC User Satisfaction and Tolerability Study

PHASE3CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

March 13, 2017

Primary Completion Date

September 3, 2018

Study Completion Date

August 5, 2022

Conditions
Contraception
Interventions
DRUG

Levonorgestrel (Kyleena, BAY86-5028)

Low-dose LNG IUS with an initial in vitro release rate of 16 μg LNG/day, used continuously. The total LNG content in LCS16 is 19.5 mg. Administered intrauterine, for 12 months with an option for extended use for up to 5 years

DRUG

Ethinyl estradiol and drospirenone (Yarina, BAY86-5131)

COC tablet containing 30 μg ethinyl estradiol and 3 mg drospirenone (taken on cycle days 1-21, inclusive, followed by a 7-day tablet-free week) for 12 months

Trial Locations (9)

115280

City Clinical Hospital #13 Moscow, Moscow

150042

Regional perinatal center, Yaroslavl

197374

LLC Medical center PRIME ROSE, Saint Petersburg

214019

Smolensk State Medical University, Smolensk

630099

LLC Reafan, Novosibirsk

"Medical Center Avicenna", Novosibirsk

656038

Altai State Medical University, Barnaul

660022

Krasnoyarsk State Medical University, Krasnoyarsk

664003

Scientific Center of family health & human reprod. problems, Irkutsk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY