Clinical trial NCT00995150: A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Official title: A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Contraception
Keywords: contraception
intrauterine
long-term
reversible
Lead sponsor: Medicines360
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 1910
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who request long-term, reversible contraception for up to 10 years.

Detailed description: This is a Phase 3, randomized, open-label, multicenter evaluation of the efficacy of a levonorgestrel-releasing intrauterine system (LNG20). The goals of the study include provision of information to understand efficacy and safety within the widest range of possible users of the LNG20. Typically, intrauterine contraceptive studies only include women 18-35 years of age for efficacy and safety, and place limits on parity and larger body size. Women outside of these characteristics also desire an effective intrauterine contraceptive. Accordingly, this study will include women who are both nulliparous and parous as well as women less than 18 years of age in the primary efficacy and safety analyses

Eligibility criteria: Inclusion Criteria:

* Healthy women requesting contraception
* 16-35 years old
* Cohort 36-45 years old
* Sexually active

Exclusion Criteria:

* Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy within 24 months of study entry
* Currently breastfeeding
* Current persistent, abnormal vaginal bleeding

Primary outcomes:
measure: Number of Pregnancies Per Year
timeFrame: 10 years
measure: Cumulative Pearl Index
timeFrame: 8 years
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: 10 Years
measure: Distribution of Bleeding Amenorrhea by 90 Day Interval
timeFrame: 8 Years
measure: Continuation Rates
timeFrame: 10 Years
measure: Return of Menses After Discontinuation
timeFrame: 5 months
measure: Return to Fertility After Discontinuation
timeFrame: 12 months
measure: Mean Plasma Levonorgestrel Concentrations (pg/mL) for Subjects in the PK Substudy
timeFrame: 5 Years
measure: Plasma LNG Levels in All Subjects With Continuing Use From Month 36 Through Month 120
timeFrame: month 36 through 120
measure: Changes in Endometrial Thickness Based on Transvaginal Ultrasonography at One Year, Five Years and Ten Years
timeFrame: 10 Years
measure: Ex Vivo Analysis of IUSs That Are Removed or Expelled During the Study
timeFrame: 8 Years
measure: Incidence of Bleeding and/or Spotting
timeFrame: 8 Years
measure: Cumulative Pregnancy Rates
timeFrame: 8 years
measure: Expulsion Rate
timeFrame: 10 years
measure: Change in Hemoglobin Values
timeFrame: 10 years
measure: Discontinuation for Safety Reasons
timeFrame: 10 years
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Palo Alto
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Vista
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Idaho Falls
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Ann Arbor
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital, University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: COO
name: Andrea Olariu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Chen BA, Eisenberg DL, Schreiber CA, Turok DK, Olariu AI, Creinin MD. Bleeding changes after levonorgestrel 52-mg intrauterine system insertion for contraception in women with self-reported heavy menstrual bleeding. Am J Obstet Gynecol. 2020 Apr;222(4S):S888.e1-S888.e6. doi: 10.1016/j.ajog.2019.11.1288. Epub 2019 Dec 19.
citation: Teal SB, Turok DK, Chen BA, Kimble T, Olariu AI, Creinin MD. Five-Year Contraceptive Efficacy and Safety of a Levonorgestrel 52-mg Intrauterine System. Obstet Gynecol. 2019 Jan;133(1):63-70. doi: 10.1097/AOG.0000000000003034.
citation: Schreiber CA, Teal SB, Blumenthal PD, Keder LM, Olariu AI, Creinin MD. Bleeding patterns for the Liletta(R) levonorgestrel 52 mg intrauterine system. Eur J Contracept Reprod Health Care. 2018 Apr;23(2):116-120. doi: 10.1080/13625187.2018.1449825. Epub 2018 Mar 21.
citation: Darney PD, Stuart GS, Thomas MA, Cwiak C, Olariu A, Creinin MD. Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use. Contraception. 2018 Mar;97(3):210-214. doi: 10.1016/j.contraception.2017.10.005. Epub 2017 Oct 13.
citation: Creinin MD, Jansen R, Starr RM, Gobburu J, Gopalakrishnan M, Olariu A. Levonorgestrel release rates over 5 years with the Liletta(R) 52-mg intrauterine system. Contraception. 2016 Oct;94(4):353-6. doi: 10.1016/j.contraception.2016.04.010. Epub 2016 Apr 25.
citation: Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD; ACCESS IUS Investigators. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015 Jul;92(1):10-6. doi: 10.1016/j.contraception.2015.04.006. Epub 2015 Apr 28.