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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019533
• Other study ID #: LR-301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 9, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: August 2023
• Source: Insud Pharma
• Contact: Elena Rojas
• Phone: +34 676 943 642
• Email: elena.rojas[@]exeltis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Combination Product:
• LVDS
Levonorgestrel Vaginal Delivery System

Locations

Country	Name	City	State
Spain	LR-301/	Móstoles	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Chemo Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pearl Index		1 year