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ACTIVE NOT RECRUITING
NCT06019533
PHASE3

A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles

Sponsor: Chemo Research

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

LVDS

Levonorgestrel Vaginal Delivery System

Locations (1)

LR-301/

Móstoles, Madrid, Spain