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.
The study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.
Healthy females ages 18-50 with heavy menstrual bleeding
Detailed Eligibility: 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
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
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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