search
Back to results

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

Primary Purpose

Menorrhagia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levonorgestrel 52 mg intrauterine system
Sponsored by
Medicines360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • MomDoc Women's Health Research
  • OB/GYN Research, University of California, Davis Health
  • Wr-McCr, Llc
  • Stanford University Medical Center, OB-GYN Clinic
  • University of Colorado Denver
  • UF Health Women's Specialists
  • Comprehensive Clinical Trials, LLC
  • Emory University School of Medicine
  • WR-Mount Vernon Clinical Research, LLC
  • CR Prime
  • Johns Hopkins Bayview Medical Center
  • University of Michigan Women's Hospital
  • Washington University in St. Louis School of Medicine
  • Rex Garn Mabey
  • Women's Health Research Center
  • M3 Wake Research, Inc.
  • University of Cincinnati Physicians Company
  • University Hospitals Cleveland Medical Center
  • The Ohio State University
  • Oregon Health and Science University
  • University of Pennsylvania
  • Thomas Jefferson University
  • Magee-Womens Hospital, Center for Family Planning
  • WR-ClinSearch, LLC
  • University of Tennessee Medical Center
  • WR-Medical Research Center of Memphis
  • Baylor College of Medicine
  • University of Utah
  • Eastern Virginia Medical-Conrad Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levonorgestrel 52 mg intrauterine system

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 20, 2018
Last Updated
August 4, 2022
Sponsor
Medicines360
search

1. Study Identification

Unique Protocol Identification Number
NCT03642210
Brief Title
Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
October 12, 2021 (Actual)
Study Completion Date
October 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicines360

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levonorgestrel 52 mg intrauterine system
Arm Type
Experimental
Arm Description
Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months
Intervention Type
Combination Product
Intervention Name(s)
Levonorgestrel 52 mg intrauterine system
Intervention Description
Levonorgestrel 52 mg intrauterine system
Primary Outcome Measure Information:
Title
Successful treatment
Description
End of treatment menstrual blood loss <80 ml and 50% or less than baseline
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Olariu, MD, PhD
Organizational Affiliation
COO
Official's Role
Study Director
Facility Information:
Facility Name
MomDoc Women's Health Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
OB/GYN Research, University of California, Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Wr-McCr, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Stanford University Medical Center, OB-GYN Clinic
City
Stanford
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UF Health Women's Specialists
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
WR-Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
CR Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
University of Michigan Women's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University in St. Louis School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Rex Garn Mabey
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Women's Health Research Center
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
M3 Wake Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
University of Cincinnati Physicians Company
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Magee-Womens Hospital, Center for Family Planning
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
WR-Medical Research Center of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
30328
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Eastern Virginia Medical-Conrad Clinical Research Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs