MedTrace Logo

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

NCT06019533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1039

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Contraception

Interventions

COMBINATION_PRODUCT

LVDS

Levonorgestrel Vaginal Delivery System

Sponsors & Collaborators

  • Chemo Research

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2025-08-01
Completion
2025-08-01

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019533 on ClinicalTrials.gov