MenorrhagiaPhase 3NCT03642210
Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
A Phase 3 study testing Levonorgestrel 52 mg intrauterine system in people with Menorrhagia, run by Medicines360 at 29 sites in United States.
Trial summary
To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Levonorgestrel 52 mg intrauterine system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 29 sitesUnited States
- Study dates
- 17 Jan 2019to 12 Oct 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 47Show fewer
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
University of Michigan Women's Hospital
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
University of Cincinnati Physicians Company
Cincinnati, Ohio, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
Baylor College of Medicine
Houston, Texas, 77030
CR Prime
Idaho Falls, Idaho, 83404
UF Health Women's Specialists
Jacksonville, Florida, 32207
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Rex Garn Mabey
Las Vegas, Nevada, 89128
Women's Health Research Center
Lawrenceville, New Jersey, 08648
WR-Medical Research Center of Memphis
Memphis, Tennessee, 30328
Eastern Virginia Medical-Conrad Clinical Research Center
Norfolk, Virginia, 23507
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Magee-Womens Hospital, Center for Family Planning
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
OB/GYN Research, University of California, Davis Health
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84132
Wr-McCr, Llc
San Diego, California, 92108
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
MomDoc Women's Health Research
Scottsdale, Arizona, 85251
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63108
Stanford University Medical Center, OB-GYN Clinic
Stanford, California, 94403
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
About this study
Official title: A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
To assess the efficacy of a levonorgestrel 52 mg intrauterine system as a treatment for heavy menstrual bleeding.
Read the detailed description
This study is a multicenter, open-label, evaluation of the efficacy and safety of LNG20 IUS for treatment of heavy menstrual bleeding.
- Conditions
- Menorrhagia
- Being tested
- Levonorgestrel 52 mg intrauterine system
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel 52 mg intrauterine systemCombination product
Levonorgestrel 52 mg intrauterine system
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel 52 mg intrauterine system | Experimental | Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months Receives: Combination Product: Levonorgestrel 52 mg intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding
Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of <80 ml or ≤50% of baseline
Measured: 6 months
Secondary outcomes (11)
Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
- Percent change from Baseline MBL to mid-treatment MBL Cycle 3 (28 days per cycle; approximately 3 months)
Measured: 3 months
Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
- Absolute change in Baseline MBL to mid-treatment MBL Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
Measured: 3 months
Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
- Absolute change from Baseline to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
Measured: 6 months
Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
- Percent change from Baseline MBL to end-of-treatment MBL Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
Measured: 6 months
Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6.
Number of days bleeding, spotting, and bleeding and/or spotting at Baseline, Cycle 3 (approximately 3 months), and Cycle 6 (approximately 6 months).
Measured: 6 months
Blood Changes - Hemoglobin
- Percent change in hemoglobin from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months).
Measured: 6 months
Blood Changes - Hematocrit
- Percent change in hematocrit from Baseline to mid-treatment (approximately 3 months), from Baseline to end-of-treatment (approximately 6 months), and from mid-treatment to end-of-treatment (approximately 3 months).
Measured: 6 months
Blood Changes - Ferritin
Change in serum ferritin from Baseline to mid-treatment (approximately 3 months) and to end-of-treatment (approximately 6 months).
Measured: 6 months
Number of Participants That Discontinued vs Completed Full Treatment Duration
Number of Participants that Discontinued vs Completed Full Treatment Duration.
Measured: 6 months
Participant Subjective Assessments
- Subjective assessment of menstrual bleeding changes based on VAS questionnaires of Safety and Continuation Rates from Baseline to Treatment Cycle 3 (approximately 3 months) to Cycle 6 (approximately 6 months). Participants responded to various questions regarding their menstrual bleeding on Visual Analog Scales (VAS), with "Not Acceptable" at 0 cm and "Completely Acceptable" at 10 cm.
Measured: 6 months
Changes in Number of Bleeding Episodes
- Changes from Baseline to mid-treatment Cycle 3 (approximately 3 months), from Baseline to end of treatment Cycle 6 (approximately 6 months), and from mid-treatment Cycle 3 to end of treatment Cycle 6 in the number of bleeding episodes. Bleeding episodes are defined as all bleeding days separated by no more than one bleeding-free day.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start17 Jan 2019
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Olariu, MD, PhD, Study director, COO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642210
- Sponsor's protocol ID
- M360-L105
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2018
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Creinin MD, Barnhart KT, Gawron LM, Eisenberg D, Mabey RG Jr, Jensen JT. Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device. Obstet Gynecol. 2023 May 1;141(5):971-978. doi: 10.1097/AOG.0000000000005137. Epub 2023 Apr 5.
PubMed 37023455
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
- ClinicalTrials.gov ID
- NCT03642210
- Acronym / sponsor ID
- M360-L105
- Conditions
- Menorrhagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Medicines360University, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 14 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel 52 mg intrauterine system | Experimental | Combination Product: Levonorgestrel 52 mg intrauterine systemLevonorgestrel 52 mg intrauterine system, inserted for use up to 6 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (47 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levonorgestrel 52 mg intrauterine systemLevonorgestrel 52 mg intrauterine system | Combination product | Levonorgestrel 52 mg intrauterine system |
Primary outcome
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding
Time frame: 6 months
Number of participants who completed treatment with an End-of-Treatment menstrual blood loss of <80 ml or ≤50% of baseline
11 secondary outcomes
Menstrual Blood Loss - Percent Change From Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
Time frame: 3 months
Menstrual Blood Loss - Absolute Change in Baseline to Cycle 3 (28 Days Per Cycle; Approximately 3 Months)
Time frame: 3 months
Menstrual Blood Loss - Absolute Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
Time frame: 6 months
Menstrual Blood Loss - Percent Change From Baseline to Cycle 6 (28 Days Per Cycle; Approximately 6 Months)
Time frame: 6 months
Change in Bleeding/Spotting Days From Baseline, Cycle 3, and Cycle 6.
Time frame: 6 months
Blood Changes - Hemoglobin
Time frame: 6 months
Blood Changes - Hematocrit
Time frame: 6 months
Blood Changes - Ferritin
Time frame: 6 months
Number of Participants That Discontinued vs Completed Full Treatment Duration
Time frame: 6 months
Participant Subjective Assessments
Time frame: 6 months
Changes in Number of Bleeding Episodes
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37023455Creinin MD, Barnhart KT, Gawron LM, Eisenberg D, Mabey RG Jr, Jensen JT. Heavy Menstrual Bleeding Treatment With a Levonorgestrel 52-mg Intrauterine Device. Obstet Gynecol. 2023 May 1;141(5):971-978. doi: 10.1097/AOG.0000000000005137. Epub 2023 Apr 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Olariu, MD, PhD study director
COO
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levonorgestrel 52 mg intrauterine system in people with Menorrhagia, run by Medicines360 at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Treatment of Heavy Menstrual Bleeding (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03642210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.