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Trial record 12 of 404 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT03642210
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : June 21, 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


  Show 24 Study Locations
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: June 21, 2019
Last Verified: June 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