Summary

for females ages 18-50 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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

Keywords

Menorrhagia Levonorgestrel Levonorgestrel 52 mg intrauterine system

Eligibility

You can join if…

Open to females ages 18-50

  • 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

You CAN'T join if...

  • 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:
  • 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: 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
  • clear evidence of adenomyosis
  • Chronic endometritis on endometrial biopsy at screening
  • 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 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
  • 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
  • . 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
  • . 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

Locations

  • OB/GYN Research, University of California, Davis Health accepting new patients
    Sacramento California 95817 United States
  • Wr-McCr, Llc accepting new patients
    San Diego California 92108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medicines360
ID
NCT03642210
Phase
Phase 3
Study Type
Interventional
Last Updated