NCT06019533

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,039

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

August 25, 2023

Last Update Submit

April 16, 2026

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • Pearl Index

    1 year

Study Arms (1)

LVDS

EXPERIMENTAL
Combination Product: LVDS

Interventions

LVDSCOMBINATION_PRODUCT

Levonorgestrel Vaginal Delivery System

LVDS

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • At Visit 1a, subjects must meet ALL of the following criteria:
  • Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
  • Women who either
  • have never used hormonal contraceptives before consent/assent (naïve users), or
  • have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or
  • directly switch from another hormonal contraceptive (switchers).
  • Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:
  • Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.

You may not qualify if:

  • Pregnancy or wish of pregnancy.
  • Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
  • History of infertility.
  • Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a.
  • Unexplained amenorrhoea.
  • Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LR-301/

Móstoles, Madrid, 28938, Spain

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

August 9, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)