Status:
ACTIVE_NOT_RECRUITING
A Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Lead Sponsor:
Chemo Research
Conditions:
Contraception
Eligibility:
FEMALE
15-45 years
Phase:
PHASE3
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, gynae...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06019533
Start Date
August 9 2023
End Date
April 30 2026
Last Update
February 21 2025
Active Locations (1)
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1
LR-301/
Móstoles, Madrid, Spain, 28938