LCS12 vs. ENG Subdermal Implant (Nexplanon) Discontinuation Rate Study
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|ClinicalTrials.gov Identifier: NCT01397097|
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : July 25, 2016
The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.
Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: LNG-IUS (BAY 86-5028) Drug: 68 mg etonorgestrel implant for subdermal use (Nexplanon)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||766 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 18 to 35 Years of Age|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||April 2015|
|Experimental: Arm 1||
Drug: LNG-IUS (BAY 86-5028)
LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months with an follow-up extension for up to 3 years
|Active Comparator: Arm 2||
Drug: 68 mg etonorgestrel implant for subdermal use (Nexplanon)
Implant insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months, may be continued up to 3 years under standard care.
- Discontinuation rate by treatment group [ Time Frame: at 12 months ]
- Discontinuation rates by treatment group [ Time Frame: at 6 months and by reason at 6 and 12 months ]
- Overall satisfaction rating and questionnaires on User satisfaction and bleeding and Contraceptive tolerability [ Time Frame: at 6 and 12 months ]
- Pregnancy rate, as determined by Pearl index [ Time Frame: at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397097
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|Study Director:||Bayer Study Director||Bayer|