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



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


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


MenorrhagiaLevonorgestrelLevonorgestrel 52 mg intrauterine system


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


  • OB/GYN Research, University of California, Davis Health accepting new patients
    SacramentoCalifornia95817United States
  • Wr-McCr, Llc accepting new patients
    San DiegoCalifornia92108United States


accepting new patients
Start Date
Completion Date
Phase 3
Study Type
Last Updated