Levonorgestrel Contraceptive Intrauterine Systems (LCS) Pearl Index Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528112
• Other study ID #: 91665
• Secondary ID: 310442G04209FG04
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: August 5, 2013
• Start date: August 2007
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2885
• Est. completion date: June 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• LCS12
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 12 microg/24 h
• LCS16
Intrauterine system (IUS) with Levonorgestrel, in vitro releasing rate 16 microg/24 h

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Finland,  France,  Hungary,  Mexico,  Netherlands,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pearl Index	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.	Up to 3 years	No
Secondary	Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 1	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.	Day 1 to Day 90	No
Secondary	Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 2	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.	Day 91 to Day 180	No
Secondary	Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 3	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.	Day 181 to Day 270	No
Secondary	Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 4	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.	Day 271 to Day 360	No
Secondary	Bleeding Patterns in Days by 90-day Reference Periods - Reference Period 12	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.	Day 991 to Day 1080	No
Secondary	Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 1	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.	Day 1 to Day 30	No
Secondary	Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 2	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.	Day 31 to Day 60	No
Secondary	Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 3	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.	Day 61 to Day 90	No
Secondary	Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 4	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.	Day 91 to Day 120	No
Secondary	Bleeding Patterns in Days by 30-day Reference Periods - Reference Period 12	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.	Day 331 to Day 360	No
Secondary	Number of Participants With/Without Ovulation - Year 1	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.	For six weeks in the second half of Year 1	No
Secondary	Number of Participants With/Without Ovulation - Year 2	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.	For six weeks in the second half of Year 2	No
Secondary	Number of Participants With/Without Ovulation - Year 3	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.	For six weeks in the second half of Year 3	No
Secondary	Average Total Cervical Score - Year 1	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)	For six weeks in the second half of Year 1	No
Secondary	Average Total Cervical Score - Year 2	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)	For six weeks in the second half of Year 2	No
Secondary	Average Total Cervical Score - Year 3	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)	For six weeks in the second half of Year 3	No
Secondary	Classification of Endometrium - Year 1	The histological evaluation of the endometrium examined the effects of progesterone on the endometrium	At Year 1	No
Secondary	Classification of Endometrium - Year 2	The histological evaluation of the endometrium examined the effects of progesterone on the endometrium	At Year 2	No
Secondary	Classification of Endometrium - Year 3 / End of Study	The histological evaluation of the endometrium examined the effects of progesterone on the endometrium	At Year 3 / End of study	No
Secondary	Degree of User Overall Satisfaction With Study Treatment	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.	At the end of study/Year 3	No
Secondary	Number of Participants With Partial or Total Expulsion	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.	Up to 3 years	No

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