Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menorrhagia | Combination Product: Levonorgestrel 52 mg intrauterine system | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 17, 2019 |
Estimated Primary Completion Date : | August 1, 2021 |
Estimated Study Completion Date : | August 1, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months
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Combination Product: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system
|
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Prior (documented within 6 months) or baseline study ultrasound examination demonstrating:
Has any of the following premalignant or malignant diseases:
Has any of the following medical conditions:
Study Director: | Andrea Olariu, MD, PhD | Interim CEO |
Tracking Information | |||||
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First Submitted Date ICMJE | August 20, 2018 | ||||
First Posted Date ICMJE | August 22, 2018 | ||||
Last Update Posted Date | February 1, 2021 | ||||
Actual Study Start Date ICMJE | January 17, 2019 | ||||
Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Successful treatment [ Time Frame: 6 months ] End of treatment menstrual blood loss <80 ml and 50% or less than baseline
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding | ||||
Official Title ICMJE | A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding | ||||
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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Menorrhagia | ||||
Intervention ICMJE | Combination Product: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system
|
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Study Arms ICMJE | Experimental: Levonorgestrel 52 mg intrauterine system
Levonorgestrel 52 mg intrauterine system, inserted for use up to 6 months
Intervention: Combination Product: Levonorgestrel 52 mg intrauterine system
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
105 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Estimated Study Completion Date ICMJE | August 1, 2021 | ||||
Estimated Primary Completion Date | August 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03642210 | ||||
Other Study ID Numbers ICMJE | M360-L105 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Medicines360 | ||||
Study Sponsor ICMJE | Medicines360 | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Medicines360 | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |