A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Primary objective: Assess the efficacy of a levonorgestrel 52 mg intrauterine system (LNG20 IUS) as a treatment for heavy menstrual bleeding. Secondary objectives: Assess safety, tolerability, bleeding patterns, and continuation rates of LNG20 IUS in women using LNG20 IUS for heavy menstrual bleeding.
This Study is
No Longer Enrolling
The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.
Adult
Healthy females ages 18-50 with heavy menstrual bleeding
1. Signed informed consent 2. Reports subjectively heavy menses for most menses when not using hormonal contraception or a copper IUD 3. Healthy females 18-50 years old, inclusive, at the time of enrollment 4. Able to read and write, as determined by study personnel 5. FSH value less than or equal to 30 mIU/mL at screening 6. Typical menstrual cycle length of 21-35 days with variation from cycle to cycle of typically 5 days or less 7. Has menstrual blood loss in 2 of the 3 cycles during the Screening Phase with ≥ 80 mL per cycle as measured by the AH method 8. Uterine sound depth of ≥5.5 cm 9. Willing to comply with study requirements including visit schedule, assessments, diary completion and feminine hygiene product use and collection 10. Documented (i.e., printed report) Pap testing and any indicated evaluation/treatment that demonstrates no need for further evaluation during the course of study participation (i.e., within 10 months after consent) 11. Planning to reside within a reasonable driving distance of a research site (approximately 150 miles) for duration of study participation 12. Willing to use a medication other than a NSAID as first-line treatment for any pain condition during the duration of study participation 13. Willing to abstain from heterosexual intercourse or use acceptable contraception during the screening phase; acceptable contraception includes male or female permanent contraception, withdrawal (if has been using as current method prior to screening) or a barrier method 14. If previously pregnant, at least one subjectively heavy menses prior to screening
Treatment
Comprehensive Women's Health Center
Comprehensive Womens Health Center
University of Colorado Hospital
Protocol Number: 18-2249
More information available at ClinicalTrials.gov: NCT03642210
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