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A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles

NCT03945513 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1034

Last updated 2023-11-14

No results posted yet for this study

Summary

The main objective of this trial is to demonstrate the contraceptive efficacy of LPRI424, Additional goals of the trial are to demonstrate the safety and tolerability of LPRI424.

Conditions

  • Contraception

Interventions

DRUG

LPRI424 (dienogest/ethinylestradiol)

One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.

Sponsors & Collaborators

  • Chemo Research

    collaborator INDUSTRY

  • Insud Pharma

    lead INDUSTRY

Principal Investigators

  • Enrico Colli, MD · Chemo Research

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2023-06-30
Completion
2023-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945513 on ClinicalTrials.gov