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

Sponsor
Chemo Research (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06019533
Collaborator
(none)
750
Enrollment
1
Location
1
Arm
32.7
Anticipated Duration (Months)
22.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: LVDS
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multicentre, Single Arm Trial on Contraceptive Efficacy, Safety and Tolerability of LVDS (Levonorgestrel Vaginal Delivery System) During 13 Cycles
Actual Study Start Date :
Aug 9, 2023
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: LVDS

Combination Product: LVDS
Levonorgestrel Vaginal Delivery System

Outcome Measures

Primary Outcome Measures

  1. Pearl Index [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts 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

  3. have never used hormonal contraceptives before consent/assent (naïve users), or

  4. 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

  5. directly switch from another hormonal contraceptive (switchers).

  6. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 LR-301/ Móstoles Madrid Spain 28938

Sponsors and Collaborators

  • Chemo Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chemo Research
ClinicalTrials.gov Identifier:
NCT06019533
Other Study ID Numbers:
  • LR-301
First Posted:
Aug 31, 2023
Last Update Posted:
Aug 31, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Aug 31, 2023