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Trial record 12 of 403 for:    LEVONORGESTREL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03642210
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medicines360

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

Condition or disease Intervention/treatment Phase
Menorrhagia Combination Product: Levonorgestrel 52 mg intrauterine system Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levonorgestrel 52 mg intrauterine system Combination Product: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system




Primary Outcome Measures :
  1. Successful treatment [ Time Frame: 6 months ]
    End of treatment menstrual blood loss <80 ml and 50% or less than baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Typical menstrual cycle length of 21-35 days or less with variation from cycle to cycle of typically 5 days of less
  • Has menstrual blood loss in 2 or the 3 cycles during the screening phase with greater than or equal to 80 mL per cycle as measured by the Alkaline Hematin Method
  • 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 used as current method prior to screening) or a barrier method

Exclusion Criteria:

  • Currently pregnant
  • Planning to attempt to become pregnancy 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 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
  • 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:

    1. a congenital or acquired uterine anomaly that distorts the uterine cavity or cervical canal incompatible with insertion;
    2. endometrial polyps (unless previously removed);
    3. fibroids meeting any of the following criteria: i. distort the uterine cavity or cervical canal incompatible with insertion; ii. submucosal location; iii. exceeding 2 cm in the greatest dimension for any individual fibroid; iv. more than three fibroids of a least 1.5 cm in greatest diameter
    4. clear evidence of adenomyosis
  • Chronic endometritis on endometrial biopsy at screening
  • Has any of the following premalignant or malignant diseases:

    1. malignant melanoma
    2. acute malignancies affecting blood or leukemias
    3. gestational trophoblastic disease (unless at least one year with undetectable beta-hCG)
    4. known or suspected cervical, ovarian, vaginal or vulvar cancer
    5. 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)
    6. history of breast cancer, or suspicion of breast cancer until proven otherwise
  • Has any of the following medical conditions:

    1. bleeding diathesis (inherited or acquired)
    2. history of von Willebrand's disease or other known coagulopathy
    3. uncontrolled significant hypertension defined as a sitting systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 95 mm Hg at any screening or enrollment visit
    4. presence or history of venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), presence or history of arterial thromboembolic diseases (e.g., myocardial infarction, stroke)
    5. uncontrolled thyroid disorder
    6. sickle cell anemia
    7. diabetes mellitus that is poorly controlled or with end-organ/vascular complications
    8. hyperprolactinemia at screening
    9. acute or severe liver disease or liver tumor
    10. history of or poorly controlled bipolar disorder, schizophrenia, psychosis, major depressive disorder or other major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders
    11. history of a positive HIV test or having a partner who is known to be HIV positive
  • 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 a 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642210


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Locations
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United States, Arizona
MomDoc Women's Health Research Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Danielle Gincastro, MA, CRC    480-305-7423    daniellegincastro@momdoc.com   
Principal Investigator: Harris         
United States, California
OB/GYN Research, University of California, Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Bridget Little    916-734-6846    hs-obgynresearch@ucdavis.edu   
Wr-McCr, Llc Recruiting
San Diego, California, United States, 92108
Contact: T. Chang    619-521-2841    tchang@mccresearch.com   
Stanford University Medical Center, OB-GYN Clinic Recruiting
Stanford, California, United States, 94403
Contact: K. Lerma    650-721-1562    klerma@stanford.edu   
United States, Colorado
University of Colorado Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Rebecca Seale    303-724-2013    rebecca.seale@ucdenver.edu   
United States, Florida
UF Health Women's Specialists Recruiting
Jacksonville, Florida, United States, 32207
Contact: Melanie S Bentley, CCRP    904-633-0772    melanie.bentley@jax.ufl.edu   
Comprehensive Clinical Trials, LLC Recruiting
West Palm Beach, Florida, United States, 33409
Contact: Ronald Ackerman, MD, FACOG    561-478-3177    jackerman@cctllc.net   
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Valerie Jean    404-778-1358    vjean@emory.edu   
Contact: Sarah Cordes    1-404-778-1358    smdicke@emory.edu   
United States, Idaho
CR Prime Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Clinical Study Coordinator    208-270-6638    nora@crprime.com   
United States, Michigan
University of Michigan Women's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Meg Urbin    734-647-1040    megurbin@med.umich.edu   
United States, Missouri
Washington University in St. Louis School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Kristen Powers    314-747-2196    kpowers@wustl.edu   
United States, Nevada
Rex Garn Mabey Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Ashlee Ross    702-242-8800    ashleeross.research@gmail.com   
United States, New Jersey
Women's Health Research Center Recruiting
Lawrenceville, New Jersey, United States, 08648
Contact: Stephanie Lee    609-799-5010    slee@scottedermd.com   
United States, North Carolina
M3 Wake Research, Inc. Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Tevnan Keller    919-781-2514    tkeller@wakeresearch.com   
Contact: Sarah Nichols    9197812514    snichols@wakeresearch.com   
United States, Ohio
University of Cincinnati Physicians Company Recruiting
Cincinnati, Ohio, United States, 45267
Contact: M. Thomas, MD    513-584-4100    researchforwomen@uchealth.com   
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bridget Ermlich    216-844-8091    bridget.ermlich@uhhospitals.org   
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Katherine Martin    614-293-0075    kathryn.martin@osumc.edu   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Reed Sheridan    503-494-7051    sheridar@ohsu.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Karen Lecks    215-349-5201    klecks@obgyn.upenn.edu   
Contact: Jessica McClucky    215-615-4206    Jessica.McClusky@uphs.upenn.edu   
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Stephanie Sendeck    215-955-9243    Stephanie.sendeck@jefferson.edu   
Magee-Womens Hospital, Center for Family Planning Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kara Armbruster    412-641-3418    bumbernickkl2@upmc.edu   
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Amanda Suttles, RN    865-305-7915    asuttles@utmck.edu   
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Maria Nunuez    832-824-0403    Maria.Nunez@bcm.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Amy Orr    801-213-2774    amy.orr@hsc.utah.edu   
United States, Virginia
Eastern Virginia Medical-Conrad Clinical Research Center Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jamie Evans    757-446-7972    evansjl@evms.edu   
Contact: Elizabeth Strode    1-757-446-7087    strodeel@evms.edu   
Sponsors and Collaborators
Medicines360
Investigators
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Study Director: Andrea Olariu, MD, PhD Chief Medical Officer

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Responsible Party: Medicines360
ClinicalTrials.gov Identifier: NCT03642210     History of Changes
Other Study ID Numbers: M360-L105
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Levonorgestrel
Menorrhagia
Hemorrhage
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral