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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06019533

Enrollment

1039

Registered

2023-08-31

Start date

2023-08-09

Completion date

2025-08-01

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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.

Interventions

COMBINATION_PRODUCTLVDS

Levonorgestrel Vaginal Delivery System

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* At Visit 1a, subjects must meet ALL of the following criteria: 1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women. 2. Women who either 1. have never used hormonal contraceptives before consent/assent (naïve users), or 2. 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 3. directly switch from another hormonal contraceptive (switchers). 3. 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.

Exclusion criteria

1. Pregnancy or wish of pregnancy. 2. 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. 3. History of infertility. 4. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to V1a. 5. Unexplained amenorrhoea. 6. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.

Design outcomes

Primary

Measure	Time frame
Pearl Index	1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026