Condition or disease | Intervention/treatment | Phase |
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Healthy Women Female Contraception | Drug: Mona Lisa® NT Cu380 Mini Drug: ParaGard® CuT380A | Phase 3 |
The total duration of the study for each participant is expected to be approximately 39 months: including screening and enrollment (up to 30 days to meet enrollment criteria), 37 months of participation, and a post-removal follow up telephone call 17 days post-removal. After enrollment, subject visits occur at 6 weeks, 3 months, 6 months, 12 months, 24 months, with telephone calls at 9, 18, and 30 months and seen again at 37 months for their final visit. Subjects will use a home pregnancy test 17 days post-removal of the IUD or Exit Visit procedures, whichever occurs first, and called by the site for the result and for safety follow-up.
Subject recruitment is expected to begin Q2 (in the second quarter of) 2017 and is planned to continue through Q2 2018. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q2 2021. The total duration of the study will be approximately 48 months for each study site including pre- and post- trial activities. The end of the study will occur when the last subject to be enrolled has completed her post-removal pregnancy test telephone call.
Total duration of the project is expected to be five years. Preliminary results of the study are expected to be available Q4 of 2019 based on the current study plan.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Other |
Official Title: | A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard |
Actual Study Start Date : | May 26, 2017 |
Estimated Primary Completion Date : | May 1, 2021 |
Estimated Study Completion Date : | November 1, 2021 |
Arm | Intervention/treatment |
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Experimental: Mona Lisa® NT Cu380 Mini
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
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Drug: Mona Lisa® NT Cu380 Mini
Mona Lisa® NT Cu380 Mini
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Active Comparator: ParaGard® CuT380A
ParaGard® CuT380A containing 380mm2 of copper surface inserted into the uterine cavity.
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Drug: ParaGard® CuT380A
ParaGard® CuT380A
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Ages Eligible for Study: | 16 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
16-40 years
o 16 and 17 year olds, where permissible by state regulations and local Institutional Review Board (IRB) approval
Exclusion Criteria:
Reported medical contraindications (Medical Eligibility Criteria category 3 or 4)14 to copper IUDs, including:
United States, California | |
Essential Access Health | |
Los Angeles, California, United States, 90010 | |
University of California, Davis | |
Sacramento, California, United States, 95817 | |
University of California, San Francisco | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80045 | |
United States, Hawaii | |
University of Hawaii | |
Honolulu, Hawaii, United States, 96826 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 | |
United States, Massachusetts | |
Boston Medical Center Corporation | |
Boston, Massachusetts, United States, 02118 | |
Planned Parenthood League of Massachusetts | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Planned Parenthood of New York | |
New York, New York, United States, 10012 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84106 | |
United States, Virginia | |
Eastern Virginia Medical School | |
Norfolk, Virginia, United States, 23507 |
Study Director: | Diana Blithe | National Institute of Child Health & Human Development (NICHD) | |
Study Director: | David Hubacher | FHI 360 |
Tracking Information | |||||||
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First Submitted Date ICMJE | February 9, 2017 | ||||||
First Posted Date ICMJE | April 21, 2017 | ||||||
Last Update Posted Date | May 15, 2019 | ||||||
Actual Study Start Date ICMJE | May 26, 2017 | ||||||
Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Pregnancy Rate [ Time Frame: 3 years ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard | ||||||
Official Title ICMJE | A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard | ||||||
Brief Summary | This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard. | ||||||
Detailed Description |
The total duration of the study for each participant is expected to be approximately 39 months: including screening and enrollment (up to 30 days to meet enrollment criteria), 37 months of participation, and a post-removal follow up telephone call 17 days post-removal. After enrollment, subject visits occur at 6 weeks, 3 months, 6 months, 12 months, 24 months, with telephone calls at 9, 18, and 30 months and seen again at 37 months for their final visit. Subjects will use a home pregnancy test 17 days post-removal of the IUD or Exit Visit procedures, whichever occurs first, and called by the site for the result and for safety follow-up. Subject recruitment is expected to begin Q2 (in the second quarter of) 2017 and is planned to continue through Q2 2018. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q2 2021. The total duration of the study will be approximately 48 months for each study site including pre- and post- trial activities. The end of the study will occur when the last subject to be enrolled has completed her post-removal pregnancy test telephone call. Total duration of the project is expected to be five years. Preliminary results of the study are expected to be available Q4 of 2019 based on the current study plan. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | ||||||
Estimated Enrollment ICMJE |
1000 | ||||||
Original Estimated Enrollment ICMJE |
600 | ||||||
Estimated Study Completion Date ICMJE | November 1, 2021 | ||||||
Estimated Primary Completion Date | May 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 | 16 Years to 40 Years (Child, 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 | NCT03124160 | ||||||
Other Study ID Numbers ICMJE | CCN016 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Health Decisions | ||||||
Study Sponsor ICMJE | Health Decisions | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Health Decisions | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |