NCT06019533

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

Name: Clinical Trial NCT06019533
Creator: Chemo Research
Keywords: Contraception, LVDS, Phase 3, combination product, clinical trial, Spain

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

Chemo Research·Phase 3·ClinicalTrials.gov·combination productRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Contraception
Drug/Device/Intervention: LVDS
Study type: Interventional
Intervention type: combination product

Sponsor & location

Primary sponsor: Chemo Research
Funder: Insud Pharma
Location: Móstoles, Spain

Timeline & enrollment

Phase: Phase 3
Start date: Aug 09, 2023
End date: Apr 30, 2026
Enrollment: 750 participants

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

Contraceptive managementOral contraceptivesOther contraceptive managementGeneral counselling and advice on contraceptionPersonal history of contraception

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06019533
Type: Non-Device Trial

About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.