Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00528112
First received: September 11, 2007
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Contraception
Drug: LCS12
Drug: LCS16
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pearl Index [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The unadjusted Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 3-year PI was obtained by dividing the number of pregnancies that occurred during the first three years of treatment by the time (in 100 women years) that the women were at risk of getting pregnant.


Secondary Outcome Measures:
  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1 [ Time Frame: Day 1 to Day 90 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2 [ Time Frame: Day 91 to Day 180 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3 [ Time Frame: Day 181 to Day 270 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4 [ Time Frame: Day 271 to Day 360 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12 [ Time Frame: Day 991 to Day 1080 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1 [ Time Frame: Day 1 to Day 30 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2 [ Time Frame: Day 31 to Day 60 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3 [ Time Frame: Day 61 to Day 90 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4 [ Time Frame: Day 91 to Day 120 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12 [ Time Frame: Day 331 to Day 360 ] [ Designated as safety issue: No ]
    The occurrence of genital bleeding was to be recorded by study subjects every day in a diary. Bleeding was to be recorded as light, normal or heavy, no bleeding, or spotting only. Spotting was defined as slight genital bleeding relative to the participant's experience.

  • Number of Participants With/Without Ovulation - Year 1 [ Time Frame: For six weeks in the second half of Year 1 ] [ Designated as safety issue: No ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.

  • Number of Participants With/Without Ovulation - Year 2 [ Time Frame: For six weeks in the second half of Year 2 ] [ Designated as safety issue: No ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.

  • Number of Participants With/Without Ovulation - Year 3 [ Time Frame: For six weeks in the second half of Year 3 ] [ Designated as safety issue: No ]
    Serum concentrations of progesterone were analyzed. All subjects with progesterone values equal to or greater than 2.5 ng/ml were assessed as having an ovulation.

  • Average Total Cervical Score - Year 1 [ Time Frame: For six weeks in the second half of Year 1 ] [ Designated as safety issue: No ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)

  • Average Total Cervical Score - Year 2 [ Time Frame: For six weeks in the second half of Year 2 ] [ Designated as safety issue: No ]

    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus.

    Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)


  • Average Total Cervical Score - Year 3 [ Time Frame: For six weeks in the second half of Year 3 ] [ Designated as safety issue: No ]
    Cervical mucus samples were analyzed to determine any effects of progesterone on the cervical mucus. Range of score: 0 (high contraceptive efficacy) to 12 (low contraceptive efficacy)

  • Classification of Endometrium - Year 1 [ Time Frame: At Year 1 ] [ Designated as safety issue: No ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  • Classification of Endometrium - Year 2 [ Time Frame: At Year 2 ] [ Designated as safety issue: No ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  • Classification of Endometrium - Year 3 / End of Study [ Time Frame: At Year 3 / End of study ] [ Designated as safety issue: No ]
    The histological evaluation of the endometrium examined the effects of progesterone on the endometrium

  • Degree of User Overall Satisfaction With Study Treatment [ Time Frame: At the end of study/Year 3 ] [ Designated as safety issue: No ]
    Overall user satisfaction was assessed by a questionnaire given to participants at the end of the study. The questionnaire was only given to participants whose end-of-study visit occurred after implementation of Protocol Amendment 3.

  • Number of Participants With Partial or Total Expulsion [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    If LCS was displaced, but still in the cervical canal, it was assessed as being partially displaced. If LCS was expelled from the uterus, it was assessed as a total expulsion.


Enrollment: 2885
Study Start Date: August 2007
Study Completion Date: June 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCS12
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
Drug: LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
Experimental: LCS16
Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
Drug: LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

Detailed Description:

Drop out-rate will be covered in Participant flow section.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528112

  Show 136 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00528112     History of Changes
Other Study ID Numbers: 91665, 310442, G04209F, G04209G, 2007-000420-40
Study First Received: September 11, 2007
Results First Received: July 11, 2012
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Contraception
Intrauterine
IUD
IUS

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 21, 2014