Return to search results       New search       Contact for this trial
 
 
 
Levonorgestrel contraceptive intrauterine systems (LCS) Pearl Index study
 
 
 
Trial ID: 91665
 
 
 
This is a study on a new low dose levonorgestrel contraceptive intrauterine systems (LCS). The purpose of the study is to investigate which of the 2 administered doses is the lowest effective intrauterine dose of Levonorgestrel (LNG) administered via the LCS for contraception during 3 years. The study was amended: the LCS16 arm will be extended up to 5 years
 
 
 
Official Title: Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) for a maximum of 3 years in women 18 to 35 years of age and an extension phase of the 16µg/24h dose group (LCS16 arm) up to 5 years
 
 
 
Product: Skyla (Levonorgestrel, BAY86-5028)
 
 
 
Indication/Disease: Contraception
 
 
 
Trial Status: Completed
Trial Start Date: 2007-08
Trial End Date: 2013-06 (Actual)
 
 
 
Trial Phase: Phase 3
 
 
 
Trial Design:
Trial Type: Interventional
Intervention: Drug
Trial Purpose: Prevention
Trial Endpoint: Safety/Efficacy Study
Allocation: Randomized
Blinding: Open Label
Assignment: Parallel Assignment
Trial Arms: 2
Participants: 2885
 
 
 
Primary Outcome:
  • Pearl Index up to 3 years
    Timeframe: Up to 3 years
  • Pearl Index for LCS16 up to 5 years
    Timeframe: Up to 5 years
 
 
 
Secondary Outcome:
  • Bleeding patterns in days by 90-day reference periods - reference period 20
    Timeframe: Day 1711 to Day 1800
  • Bleeding patterns in days by 90-day reference periods - reference period 13
    Timeframe: Day 1081 to Day 1170
  • Degree of user overall satisfaction with study treatment
    Timeframe: At the end of study/Year 3
  • Number of participants with partial or total expulsion
    Timeframe: Up to 3 years
  • Classification of endometrium – Year 3 / End of study
    Timeframe: At Year 3 / End of study
  • Classification of endometrium – Year 2
    Timeframe: At Year 2
  • Average total cervical score – Year 3
    Timeframe: For six weeks in the second half of Year 3
  • Classification of endometrium – Year 1
    Timeframe: At Year 1
  • Average total cervical score – Year 2
    Timeframe: For six weeks in the second half of Year 2
  • Average total cervical score – Year 1
    Timeframe: For six weeks in the second half of Year 1
  • Number of participants with/without ovulation – Year 3
    Timeframe: For six weeks in the second half of Year 3
  • Number of participants with/without ovulation – Year 2
    Timeframe: For six weeks in the second half of Year 2
  • Number of participants with/without ovulation – Year 1
    Timeframe: For six weeks in the second half of Year 1
  • Bleeding patterns in days by 30-day reference periods - reference period 12
    Timeframe: Day 331 to Day 360
  • Bleeding patterns in days by 30-day reference periods - reference period 4
    Timeframe: Day 91 to Day 120
  • Bleeding patterns in days by 30-day reference periods - reference period 3
    Timeframe: Day 61 to Day 90
  • Bleeding patterns in days by 30-day reference periods - reference period 2
    Timeframe: Day 31 to Day 60
  • Bleeding patterns in days by 30-day reference periods - reference period 1
    Timeframe: Day 1 to Day 30
  • Bleeding patterns in days by 90-day reference periods - reference period 12
    Timeframe: Day 991 to Day 1080
  • Bleeding patterns in days by 90-day reference periods - reference period 4
    Timeframe: Day 271 to Day 360
  • Bleeding patterns in days by 90-day reference periods - reference period 3
    Timeframe: Day 181 to Day 270
  • Bleeding patterns in days by 90-day reference periods - reference period 2
    Timeframe: Day 91 to Day 180
  • Bleeding patterns in days by 90-day reference periods - reference period 1
    Timeframe: Day 1 to Day 90
  • Degree of user overall satisfaction with study treatment up to 5 years
    Timeframe: At the end of study/Year 5
  • Number of participants with partial or total expulsion up to 5 years
    Timeframe: Up to 5 years
 
 
 
Eligibility Criteria:
Minimum Age: 18 Years
Maximum Age: 35 Years
Gender: Female
Healthy Volunteers: Yes

Inclusion Criteria:
  • Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
  • Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:
  • Known or suspected pregnancy or is lactating.
  • History of ectopic pregnancies.
  • Any genital infection (until successfully treated).
  • Abnormal uterine bleeding of unknown origin.
 
 
 
Additional Information: Drop out-rate will be covered in Participant flow section.
 
 
 
Sponsor: Bayer
 
 
 
Countries:
SwedenCompleted
NorwayCompleted
NetherlandsCompleted
MexicoCompleted
HungaryCompleted
FranceCompleted
FinlandCompleted
ChileCompleted
CanadaCompleted
ArgentinaCompleted
United StatesCompleted
 
 
 
Results Synopsis: PDF File
 
 
 
Relevant Links: Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for drug information provided by the FDA.
 
 
 
   
This information is provided by Bayer under Bayer's disclaimer for publication of clinical trial information.