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Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles

NCT02269241 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1552

Last updated 2019-08-06

Study results available
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Summary

To demonstrate the contraceptive efficacy of LF111 . To demonstrate the safety and tolerability of LF111 and assessment of pharmacokinetics of LF111.

Conditions

  • Contraception

Interventions

DRUG

LF111 (drospirenone)

One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.

Sponsors & Collaborators

  • Chemo France

    collaborator INDUSTRY

  • Laboratories Leon Farma, S.A.

    lead INDUSTRY

Principal Investigators

  • Enrico Colli, MD · Exeltis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-09
Primary Completion
2017-10-04
Completion
2017-10-04

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 NCT02269241 on ClinicalTrials.gov