A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles - Trial NCT06019533
Access comprehensive clinical trial information for NCT06019533 through Pure Global AI's free database. This Phase 3 trial is sponsored by Chemo Research and is currently Recruiting. The study focuses on Contraception. Target enrollment is 750 participants.
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Study Focus
Sponsor & Location
Chemo Research
Insud Pharma
Timeline & Enrollment
Phase 3
Aug 09, 2023
Apr 30, 2026
Primary Outcome
Pearl Index
Summary
Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13
 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy
 tests, gynaecological examinations, laboratory tests and a quality of life questionnaire.
 Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only).
 The women will be provided with an e-diary app for their smartphone, to record IP use and
 vaginal bleeding.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06019533
Non-Device Trial