At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,105 enrolled
Drug / intervention
Mona Lisa® NT Cu380 Mini +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
In Brief
A Phase 3 clinical trial evaluating Mona Lisa® NT Cu380 Mini and ParaGard® TCu380A for Healthy Women and Female Contraception. Completed, enrolled 1,105 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Women, Female Contraception
CountriesUnited States
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionJun 2022
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartMay 26, 2017
Primary CompletionJun 6, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.2 years ago
Interventions
Mona Lisa® NT Cu380 Minidrug
copper intrauterine device
ParaGard® TCu380Adrug
copper intrauterine device