Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05303636 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jul 2026 to Dec 2027v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1710 to confirmed 1536
    • Study sites: 20 to 37
    • Study completion date: Mar 2027 to Jun 2028
    • Interventions: LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet (Drug) to drospirenone 4 mg oral tablet or drospirenone 3.5 mg chewable tablet (Drug)
  2. Primary completion date: Dec 2025 to Jul 2026v4 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 19 to 20
    • Interventions: LF111 (drospirenone) (Drug) to LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet (Drug)
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints revised (16)
    • Study description expanded, about 47 words
    • Study title expanded, about 1 word
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 19
    • Start date changed from estimate of Apr 2022 to Mar 28, 2022
    v3
  4. Eligibility criteria revised
    • Secondary endpoints revised (16)
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of this study is to evaluate the impact of LF111 and drospirenone (DRSP) 3.5 mg chewable tablets on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods. Secondary objectives include further evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on BMD and bone turnover after 12 months (13 medication cycles) in comparison to non-hormonal contraceptive methods and assessing the general safety and tolerability of LF111 and DRSP 3.5 mg chewable tablets in comparison to non-hormonal contraceptive methods. Exploratory objectives include evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on body fat and lean mass after 12 months (13 medication cycles) of investigation.
Trial Details
NCT Number NCT05303636
Lead Sponsor Insud Pharma
Collaborators: Chemo Research
Conditions
(from sponsor)		 Change in Bone Mineral Density, Bone Loss
Related terms Bone Diseases, Metabolic, Osteoporosis
Enrollment 1,536 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov