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Trial record 12 of 405 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 : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medicines360

Tracking Information
First Submitted Date  ICMJE August 20, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2018)
Successful treatment [ Time Frame: 6 months ]
End of treatment menstrual blood loss <80 ml and 50% or less than baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03642210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Official Title  ICMJE A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Brief Summary To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menorrhagia
Intervention  ICMJE Combination Product: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system
Study Arms  ICMJE Experimental: Levonorgestrel 52 mg intrauterine system
Intervention: Combination Product: Levonorgestrel 52 mg intrauterine system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03642210
Other Study ID Numbers  ICMJE M360-L105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medicines360
Study Sponsor  ICMJE Medicines360
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrea Olariu, MD, PhD Chief Medical Officer
PRS Account Medicines360
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP