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

Completed · Phase 3

Conditions studied: Menorrhagia

In brief

To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.

Key facts

Study ID

NCT03642210

Run by

Medicines360

People needed

105

Starts

2019-01-17

Expected to finish

2021-10-12

Last updated by the study team

2024-05-14

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 insertion (unless successfully treated and considered clinically cured for at least 7 days prior to enrollment)
• History of pelvic actinomycosis infection (i.e., received antibiotic treatment; criterion does not include solely a history of Pap test with actinomyces)
• Postpartum or post-abortion endometritis unless symptoms resolved at least 4 weeks prior to screening
• Chronic endometritis on endometrial biopsy at screening (an endometrial biopsy performed within 6 months of Visit 1 could be used if a report is available with a tissue diagnosis)
• Has any of the following premalignant or malignant diseases:
• Malignant melanoma
• Acute malignancies affecting blood or leukemias
• Gestational trophoblastic disease (unless at least one year with undetectable beta-hCG)
• Known or suspected cervical, ovarian, vaginal or vulvar cancer
• Uterine cancer or evidence of uterine malignancy, endometrial intraepithelial neoplasia (EIN) or hyperplasia on an endometrial biopsy at screening (an endometrial biopsy performed within 6 months of Visit 1 could be used if a report is available with a tissue diagnosis)
• History of breast cancer, or suspicion of breast cancer until proven otherwise
• Has any of the following medical conditions:

Where it is running

• MomDoc Women's Health Research — Scottsdale, Arizona, United States
• OB/GYN Research, University of California, Davis Health — Sacramento, California, United States
• Wr-McCr, Llc — San Diego, California, United States
• Stanford University Medical Center, OB-GYN Clinic — Stanford, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• UF Health Women's Specialists — Jacksonville, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• WR-Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
• CR Prime — Idaho Falls, Idaho, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• University of Michigan Women's Hospital — Ann Arbor, Michigan, United States
• Washington University in St. Louis School of Medicine — St Louis, Missouri, United States
• Rex Garn Mabey — Las Vegas, Nevada, United States
• Women's Health Research Center — Lawrenceville, New Jersey, United States
• M3 Wake Research, Inc. — Raleigh, North Carolina, United States
• University of Cincinnati Physicians Company — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Magee-Womens Hospital, Center for Family Planning — Pittsburgh, Pennsylvania, United States
• WR-ClinSearch, LLC — Chattanooga, Tennessee, United States
• University of Tennessee Medical Center — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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