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

April 18, 2024 updated by: Medicines360

A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • MomDoc Women's Health Research
    • California
      • Sacramento, California, United States, 95817
        • OB/GYN Research, University of California, Davis Health
      • San Diego, California, United States, 92108
        • Wr-McCr, Llc
      • Stanford, California, United States, 94403
        • Stanford University Medical Center, OB-GYN Clinic
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Florida
      • Jacksonville, Florida, United States, 32207
        • UF Health Women's Specialists
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials, Llc
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Sandy Springs, Georgia, United States, 30328
        • WR-Mount Vernon Clinical Research, LLC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • CR Prime
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Women's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University in St. Louis School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Rex Garn Mabey
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Women's Health Research Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • M3 Wake Research, Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Physicians Company
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital, Center for Family Planning
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-Clinsearch, LLC
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
      • Memphis, Tennessee, United States, 30328
        • WR-Medical Research Center of Memphis
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical-Conrad Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 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:

    • Bleeding diathesis (inherited or acquired)
    • History of von Willebrand's disease or other known coagulopathy
    • Uncontrolled significant hypertension defined as a sitting systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 95 mm Hg at any screening or enrollment visit unless treated and controlled within two weeks of discovery
    • Presence or history of venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), presence or history of arterial thromboembolic diseases (e.g., myocardial infarction, stroke)
    • Uncontrolled thyroid disorder
    • Sickle cell anemia
    • Diabetes mellitus that is poorly controlled or with end-organ/vascular complications
    • Hyperprolactinemia at screening
    • Acute or severe liver disease or liver tumor
    • Poorly controlled bipolar disorder, schizophrenia, psychosis, major depressive disorder or other major psychiatric disorder according the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-5)
    • History of a positive HIV test or having a partner who is known to be HIV positive
    • Current or history of alcohol, illicit drug or prescription drug abuse within 12 months prior to screening
  • Use of antifibrinolytics, platelet aggregation inhibitors, anticoagulants or other similar medications that can increase or decrease bleeding within 30 days prior to and during the screening (EXCEPTION: NSAIDs can be used as second-line treatment for pain management)
  • Use of intrauterine or implantable contraception, progestin-only pills, combined hormonal contraceptives or oral progestin therapy within 30 days before screening
  • Depomedroxyprogesterone acetate (DMPA) injection within the past 9 months prior to screening (this exclusionary time period can be shortened to 6 months if the subject has also had two spontaneous menstrual cycles [requires minimum of 3 heavy menses] that meet criteria for normal menstrual cycle pattern)
  • Use of non-contraceptive estrogen, progesterone, progestin, testosterone, androgen or other gonadotropins (e.g. hCG) within 30 days before screening
  • Prior total or partial endometrial ablation or resection
  • History of a uterine aspiration or curettage procedure for any indication (other than an office biopsy) within 4 weeks of screening
  • Known or suspected allergy to levonorgestrel or hypersensitivity to any component of the product
  • Use of an experimental medication or receipt of an experimental treatment for any condition within 30 days of screening
  • Study staff or a member of the immediate family of a study staff
  • Any condition or circumstance that, in the opinion of the Investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as any concurrent medical condition that is not stable and well-controlled, that is likely to worsen, or that may require recurrent hospitalizations during study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months
Combination product: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding
Time Frame: 6 months
Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of <80 ml or ≤50% of baseline
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
Time Frame: 3 months
• Percent change from Baseline MBL to mid-treatment MBL 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)
Time Frame: 3 months
• Absolute change in Baseline MBL to mid-treatment MBL 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)
Time Frame: 6 months
• Absolute change from Baseline to end-of-treatment MBL 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)
Time Frame: 6 months
• Percent change from Baseline MBL to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
6 months
Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6.
Time Frame: 6 months
Number of days bleeding, spotting, and bleeding and/or spotting at Baseline, Cycle 3 (approximately 3 months), and Cycle 6 (approximately 6 months).
6 months
Blood Changes - Hemoglobin
Time Frame: 6 months
• Percent change in hemoglobin from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months).
6 months
Blood Changes - Hematocrit
Time Frame: 6 months
• Percent change in hematocrit from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months).
6 months
Blood Changes - Ferritin
Time Frame: 6 months
Change in serum ferritin from Baseline to mid-treatment (approximately 3 months) and to end-of-treatment (approximately 6 months).
6 months
Number of Participants That Discontinued vs Completed Full Treatment Duration
Time Frame: 6 months
Number of Participants that Discontinued vs Completed Full Treatment Duration.
6 months
Participant Subjective Assessments
Time Frame: 6 months
• Subjective assessment of menstrual bleeding changes based on VAS questionnaires of Safety and Continuation Rates from Baseline to Treatment Cycle 3 (approximately 3 months) to Cycle 6 (approximately 6 months). Participants responded to various questions regarding their menstrual bleeding on Visual Analog Scales (VAS), with "Not Acceptable" at 0 cm and "Completely Acceptable" at 10 cm.
6 months
Changes in Number of Bleeding Episodes
Time Frame: 6 months
• Changes from Baseline to mid-treatment Cycle 3 (approximately 3 months), from Baseline to end of treatment Cycle 6 (approximately 6 months), and from mid-treatment Cycle 3 to end of treatment Cycle 6 in the number of bleeding episodes. Bleeding episodes are defined as all bleeding days separated by no more than one bleeding-free day.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medicines360

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrea Olariu, MD, PhD, COO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M360-L105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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