Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu
Trial record 12 of 411 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. Identifier: NCT03642210
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):

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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT03642210

Hide Hide 27 study locations
Layout table for location information
United States, Arizona
MomDoc Women's Health Research Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Danielle Gincastro, MA, CRC    480-305-7423   
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   
Wr-McCr, Llc Recruiting
San Diego, California, United States, 92108
Contact: T. Chang    619-521-2841   
Stanford University Medical Center, OB-GYN Clinic Recruiting
Stanford, California, United States, 94403
Contact: K. Lerma    650-721-1562   
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Rebecca Seale    303-724-2013   
Contact: Eva Dindinger    1-303-724-8482   
United States, Florida
UF Health Women's Specialists Recruiting
Jacksonville, Florida, United States, 32207
Contact: Melanie S Bentley, CCRP    904-633-0772   
Comprehensive Clinical Trials, LLC Active, not recruiting
West Palm Beach, Florida, United States, 33409
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Valerie Jean    404-778-1358   
Contact: Sarah Cordes    1-404-778-1358   
United States, Idaho
CR Prime Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Clinical Study Coordinator    208-270-6638   
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Katrina Thaler    410-550-8506   
Contact: Barbara Chase    1-410-955-5692   
United States, Michigan
University of Michigan Women's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Meg Urbin    734-647-1040   
United States, Missouri
Washington University in St. Louis School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Kristen Powers    314-747-2196   
United States, Nevada
Rex Garn Mabey Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Ashlee Ross    702-242-8800   
United States, New Jersey
Women's Health Research Center Recruiting
Lawrenceville, New Jersey, United States, 08648
Contact: Stephanie Lee    609-799-5010   
United States, North Carolina
M3 Wake Research, Inc. Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Tevnan Keller    919-781-2514   
Contact: Sarah Nichols    9197812514   
United States, Ohio
University of Cincinnati Physicians Company Recruiting
Cincinnati, Ohio, United States, 45267
Contact: M. Thomas, MD    513-584-4100   
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bridget Ermlich    216-844-8091   
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Katherine Martin    614-293-0075   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Reed Sheridan    503-494-7051   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Karen Lecks    215-349-5201   
Contact: Jessica McClucky    215-615-4206   
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Stephanie Sendeck    215-955-9243   
Magee-Womens Hospital, Center for Family Planning Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kara Armbruster    412-641-3418   
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Amanda Suttles, RN    865-305-7915   
WR-Medical Research Center of Memphis Recruiting
Memphis, Tennessee, United States, 30328
Contact: Blair Longserre    919-781-2514   
Contact: LaShonda Herndon    9197812514      
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Maria Nunuez    832-824-0403   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Amy Orr    801-213-2774   
United States, Virginia
Eastern Virginia Medical-Conrad Clinical Research Center Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jamie Evans    757-446-7972   
Contact: Elizabeth Strode    1-757-446-7087   
Sponsors and Collaborators
Layout table for investigator information
Study Director: Andrea Olariu, MD, PhD Chief Medical Officer

Layout table for additonal information
Responsible Party: Medicines360 Identifier: NCT03642210    
Other Study ID Numbers: M360-L105
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
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