At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,552 enrolled
Drug / intervention
LF111 (drospirenone)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles
In Brief
A Phase 3 clinical trial evaluating LF111 (drospirenone) for Contraception. Completed, enrolled 1,552 participants across 37 sites.
Detailed Summary
To demonstrate the contraceptive efficacy of LF111 . To demonstrate the safety and tolerability of LF111 and assessment of pharmacokinetics of LF111.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
CollaboratorsChemo France
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionOct 2017
TodayJul 2026
First PostedOct 21, 2014
Enrollment StartOct 9, 2014
Primary CompletionOct 4, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.7 years ago
Interventions
LF111 (drospirenone)drug
One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.