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

Sponsor
Medicines360 (Other)
Overall Status
Completed
CT.gov ID
NCT03642210
Collaborator
(none)
105
Enrollment
29
Locations
1
Arm
32.8
Actual Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
N/A
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 :
Jan 17, 2019
Actual Primary Completion Date :
Oct 12, 2021
Actual Study Completion Date :
Oct 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Levonorgestrel 52 mg intrauterine system

Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months

Combination Product: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system

Outcome Measures

Primary Outcome Measures

  1. Successful treatment [6 months]

    End of treatment menstrual blood loss <80 ml and 50% or less than baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Signed informed consent

  • 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

  • Able to read and write, as determined by study personnel

  • FSH value ≤30 mIU/mL at screening

  • Typical menstrual cycle length of 21-35 days with variation from cycle to cycle of typically 5 days or less

  • Has menstrual blood loss in 2 of the 3 cycles during the Screening Phase with ≥ 80 mL per cycle as measured by the AH method

  • Uterine sound depth of ≥5.5 cm

  • Willing to comply with study visit schedule and assessments, including sanitary product collection and diary completion requirements

  • Documented (i.e., printed report) Pap testing, regardless of subject's age, and any indicated evaluation/treatment that demonstrates no need for further evaluation during the course of study participation (i.e., within 10 months after consent)

  • Planning to reside within a reasonable driving distance of a research site (approximately 150 miles) for duration of study participation

  • 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 using as current method prior to screening) or a barrier method

  • If previously pregnant, at least one subjectively heavy menses prior to screening

Exclusion Criteria:

  • Currently pregnant

  • Planning to attempt to become pregnant 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 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

  • Body habitus or history of lower genital tract abnormalities or prior surgeries which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented

  • 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: Distort the uterine cavity or cervical canal incompatible with insertion; Submucosal location; Exceeding 2 cm in the greatest dimension for any individual fibroid; More than three fibroids of at least 1.5 cm in greatest diameter

  • Clear evidence of adenomyosis consisting of any of the following: Subendometrial cysts; Diffuse adenomyosis based on a heterogeneous myometrial echotexture consisting of Hyperechoic findings (islands of endometrial glands), hypoechoic findings (associated muscle hypertrophy), or "Venetian blind" appearance due to subendometrial echogenic linear striations and acoustic shadowing where endometrial tissues cause a hyperplastic reaction.

  • Recently diagnosed or clinically evident cervicitis or upper genital tract infection at the time of IUS insertion (unless successfully treated and considered clinically cured for at least 7 days prior to enrollment)

  • History of pelvic actinomycosis infection (i.e., received antibiotic treatment; criterion does not include solely a history of Pap test with actinomyces)

  • Postpartum or post-abortion endometritis unless symptoms resolved at least 4 weeks prior to screening

  • Chronic endometritis on 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)

  • 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 ≥ 160 mm Hg or diastolic blood pressure ≥ 95 mm Hg at any screening or enrollment visit unless treated and controlled within two weeks of discovery

  • 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

  • Poorly controlled bipolar disorder, schizophrenia, psychosis, major depressive disorder or other major psychiatric disorder according the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-5)

  • History of a positive HIV test or having a partner who is known to be HIV positive

  • Current or history of alcohol, illicit drug or prescription drug abuse within 12 months prior to screening

  • 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 as 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 (this exclusionary time period can be shortened to 6 months if the subject has also had two spontaneous menstrual cycles [requires minimum of 3 heavy menses] that meet criteria for normal menstrual cycle pattern)

  • 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

  • Known or suspected allergy to levonorgestrel or hypersensitivity to any component of the product

  • Use of an experimental medication or receipt of an experimental treatment for any condition within 30 days of screening

  • Study staff or a member of the immediate family of a study staff

  • Any condition or circumstance that, in the opinion of the Investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as any concurrent medical condition that is not stable and well-controlled, that is likely to worsen, or that may require recurrent hospitalizations during study participation

Contacts and Locations

Locations

Site City State Country Postal Code
1 MomDoc Women's Health Research Scottsdale Arizona United States 85251
2 OB/GYN Research, University of California, Davis Health Sacramento California United States 95817
3 Wr-McCr, Llc San Diego California United States 92108
4 Stanford University Medical Center, OB-GYN Clinic Stanford California United States 94403
5 University of Colorado Denver Aurora Colorado United States 80045
6 UF Health Women's Specialists Jacksonville Florida United States 32207
7 Comprehensive Clinical Trials, LLC West Palm Beach Florida United States 33409
8 Emory University School of Medicine Atlanta Georgia United States 30322
9 WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia United States 30328
10 CR Prime Idaho Falls Idaho United States 83404
11 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224
12 University of Michigan Women's Hospital Ann Arbor Michigan United States 48109
13 Washington University in St. Louis School of Medicine Saint Louis Missouri United States 63108
14 Rex Garn Mabey Las Vegas Nevada United States 89128
15 Women's Health Research Center Lawrenceville New Jersey United States 08648
16 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
17 University of Cincinnati Physicians Company Cincinnati Ohio United States 45267
18 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
19 The Ohio State University Columbus Ohio United States 43210
20 Oregon Health and Science University Portland Oregon United States 97239
21 University of Pennsylvania Philadelphia Pennsylvania United States 19104
22 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
23 Magee-Womens Hospital, Center for Family Planning Pittsburgh Pennsylvania United States 15213
24 WR-ClinSearch, LLC Chattanooga Tennessee United States 37421
25 University of Tennessee Medical Center Knoxville Tennessee United States 37920
26 WR-Medical Research Center of Memphis Memphis Tennessee United States 30328
27 Baylor College of Medicine Houston Texas United States 77030
28 University of Utah Salt Lake City Utah United States 84132
29 Eastern Virginia Medical-Conrad Clinical Research Center Norfolk Virginia United States 23507

Sponsors and Collaborators

  • Medicines360

Investigators

  • Study Director: Andrea Olariu, MD, PhD, COO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medicines360
ClinicalTrials.gov Identifier:
NCT03642210
Other Study ID Numbers:
  • M360-L105
First Posted:
Aug 22, 2018
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Menorrhagia
Levonorgestrel

Study Results

No Results Posted as of Aug 9, 2022