Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

Inclusion Criteria

• Signed informed consent
• Reports subjectively heavy menses for most menses when not using hormonal contraception or a copper IUD
• Healthy females 18-50 years old, inclusive, at the time of enrollment
• Able to read and write, as determined by study personnel
• FSH value ≤30 mIU/mL at screening
• Typical menstrual cycle length of 21-35 days with variation from cycle to cycle of typically 5 days or less
• 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
• Uterine sound depth of ≥5.5 cm
• Willing to comply with study visit schedule and assessments, including sanitary product collection and diary completion requirements
• Documented (i.e., printed report) Pap testing, regardless of subject's age, 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)
• Planning to reside within a reasonable driving distance of a research site (approximately 150 miles) for duration of study participation
• Willing to use a medication other than a NSAID as first-line treatment for any pain condition during the duration of study participation
• 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
• If previously pregnant, at least one subjectively heavy menses prior to screening

Exclusion Criteria

• Currently pregnant
• Planning to attempt to become pregnant during the screening and treatment phases of study participation (i.e., up to approximately 11 months after consent)
• Currently lactating or not having a subjectively heavy menses since discontinuation of lactation prior to screening
• Clinical diagnosis of perimenopause (in the opinion of the investigator) based on one or more of the following: changes in menstrual regularity (e.g., shorter, longer, absent, irregular), hot flashes, sleeping disorder, or changes in mood (e.g., depression, nervous tension, and irritability) within 3 months prior to or during the screening period
• Screening blood laboratory value outside of the normal range that, in the opinion of the investigator, requires treatment or further work-up (i.e., are considered clinically significant)
• Has poor venous access or significant history of inability to have blood samples drawn
• Body habitus or history of lower genital tract abnormalities or prior surgeries which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented
• History of bicornuate uterus or any other abnormality of the uterus resulting in distortion of the uterine cavity or cervical canal incompatible with insertion
• Prior (documented within 6 months) or baseline study ultrasound examination demonstrating:
• A congenital or acquired uterine anomaly that distorts the uterine cavity or cervical canal incompatible with insertion;
• Endometrial polyps (unless previously removed),
• Fibroids meeting any of the following criteria: Distort the uterine cavity or cervical canal incompatible with insertion; Submucosal location; Exceeding 2 cm in the greatest dimension for any individual fibroid; More than three fibroids of at least 1.5 cm in greatest diameter
• Clear evidence of adenomyosis consisting of any of the following: Subendometrial cysts; Diffuse adenomyosis based on a heterogeneous myometrial echotexture consisting of Hyperechoic findings (islands of endometrial glands), hypoechoic findings (associated muscle hypertrophy), or "Venetian blind" appearance due to subendometrial echogenic linear striations and acoustic shadowing where endometrial tissues cause a hyperplastic reaction.
• Recently diagnosed or clinically evident cervicitis or upper genital tract infection at the time of IUS