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A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Sponsor: Chemo Research
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.
Official title: A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Key Details
Gender
FEMALE
Age Range
15 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2023-08-09
Completion Date
2026-04-30
Last Updated
2025-02-21
Healthy Volunteers
Yes
Conditions
Interventions
LVDS
Levonorgestrel Vaginal Delivery System
Locations (1)
LR-301/
Móstoles, Madrid, Spain