NCT03074045

LCS16 vs. COC User Satisfaction and Tolerability Study

Multi-center, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 16 μg LNG/Day Initial in Vitro Release Rate (LCS16) in Comparison to a Combined Oral Contraceptive (COC) Containing 30 μg Ethinyl Estradiol and 3 mg Drospirenone (Yarina®) in Young Nulliparous and Parous Women (18 - 29 Years) Over 12 Months of Use (With an Option for Extended Use of LCS16 for up to 5 Years)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 29 Years
• Healthy volunteers: Not accepted

Summary

To evaluate user satisfaction in young nulliparous and parous women (18-29 years of age \[inclusive\]), using LCS16 compared to a COC over a period of 12 months.

Conditions

• Contraception

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-13
• Primary completion: 2018-09-03
• Completion: 2022-08-05
• First posted: 2017-03-08
• Last updated: 2023-06-18

Locations

9 sites across 1 country: Russia