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

NCT03642210 | Completed Phase 3 Results FDA Drug

• 1 other identifier: M360-L105
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Treatment of Heavy Menstrual Bleeding

  Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of \<80 ml or ≤50% of baseline

  6 months

Secondary Outcomes (11)

• Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)

  3 months

• Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)

  3 months

• Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)

  6 months

• Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)

  6 months

• Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6.

  6 months

Study Arms (1)

Levonorgestrel 52 mg intrauterine system

EXPERIMENTAL

Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months

Combination Product: Levonorgestrel 52 mg intrauterine system

Interventions

Levonorgestrel 52 mg intrauterine system COMBINATION_PRODUCT

Levonorgestrel 52 mg intrauterine system

Levonorgestrel 52 mg intrauterine system

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Medicines360: lead

Study Sites (29)

MomDoc Women's Health Research

Scottsdale, Arizona, 85251, United States

Location

OB/GYN Research, University of California, Davis Health

Sacramento, California, 95817, United States

Location

Wr-McCr, Llc

San Diego, California, 92108, United States

Location

Stanford University Medical Center, OB-GYN Clinic

Stanford, California, 94403, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

UF Health Women's Specialists

Jacksonville, Florida, 32207, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

CR Prime

Idaho Falls, Idaho, 83404, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

University of Michigan Women's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63108, United States

Location

Rex Garn Mabey

Las Vegas, Nevada, 89128, United States

Location

Women's Health Research Center

Lawrenceville, New Jersey, 08648, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati Physicians Company

Cincinnati, Ohio, 45267, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Magee-Womens Hospital, Center for Family Planning

Pittsburgh, Pennsylvania, 15213, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

WR-Medical Research Center of Memphis

Memphis, Tennessee, 30328, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Eastern Virginia Medical-Conrad Clinical Research Center

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Creinin MD, Barnhart KT, Gawron LM, Eisenberg D, Mabey RG Jr, Jensen JT. Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device. Obstet Gynecol. 2023 May 1;141(5):971-978. doi: 10.1097/AOG.0000000000005137. Epub 2023 Apr 5.

  PMID: 37023455 DERIVED

MeSH Terms

Conditions

Menorrhagia

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Emily Morris
• Organization: Medicines360

emorris@medicines360.org

415.951.8700

Study Officials

• Andrea Olariu, MD, PhD

  COO

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: January 17, 2019
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)