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

NCT ID: NCT06019533

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2026-04-30

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

LVDS

Group Type: EXPERIMENTAL

LVDS

Intervention Type: COMBINATION_PRODUCT

Levonorgestrel Vaginal Delivery System

Interventions

LVDS

Levonorgestrel Vaginal Delivery System

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chemo Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LR-301/

Móstoles, Madrid, Spain

Countries

Spain

Other Identifiers

LR-301

Identifier Type: -

Identifier Source: org_study_id