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LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
NCT05303636 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet
Study Locations (20)
Florida
- Advanced Clinical Research Network — Coral Gables
- Health Care Family Rehab & Research Center — Hialeah
- Vital Pharma Research — Hialeah
- Cornerstone Research Institute — Longwood
- New Age Medical Research Corporation — Miami
- Florida Pharmaceutical Research and Associates, Inc. — South Miami
- Comprehensive Clinical Research, LLC — West Palm Beach
Texas
- Corpus Christi Women's Clinic — Corpus Christi
- Signature Gyn Services — Fort Worth
- TMC Life Research, Inc. — Houston
Louisiana
- Tandem Clinical Research — Marrero
- Clinical Trials Management, LLC - Southshore — Metairie
Arizona
- Cactus Clinical Research, Inc. — Phoenix
Colorado
- Velocity Clinical Research — Denver
Georgia
- M3 Wake Research, Inc. — Sandy Springs
Idaho
- Family Care Research — Boise
Nebraska
- Meridian Clinical Research — Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,710 participants |
| Start Date | 2022-03-28 |
| Est. Completion | 2027-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05303636
The ClinicalTrials.gov registry entry for NCT05303636 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,710 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insud Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Bone Loss appearing as the primary indexed condition, and to 1 intervention — of which LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05303636 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05303636 about?
NCT05303636 is a clinical study titled "LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women". 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 i...
What is the current status of trial NCT05303636?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,710 participants. The study started on 2022-03-28. Estimated completion is 2027-03.
What conditions does trial NCT05303636 study?
This clinical trial studies the following conditions: Bone Loss, Change in Bone Mineral Density. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05303636?
The interventions under investigation include: LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05303636?
This trial is sponsored by Insud Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05303636 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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