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NCT05303636 · ClinicalTrials.gov registry record · Phase 4
LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
A Phase 4 study of Bone Loss and Change in Bone Mineral Density, sponsored by Insud Pharma.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,710
- Enrollment target
- 20
- Study locations
NCT05303636: Recruiting Phase 4 study of Bone Loss and Change in Bone Mineral Density, sponsored by Insud Pharma.
NCT05303636 is a Phase 4 study of Bone Loss and Change in Bone Mineral Density that is actively recruiting participants, run by Insud Pharma. The registered enrollment target is 1,710 participants, above the 148-participant average among 16 other Bone Loss trials with a reported enrollment target (1055% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05303636, a Phase 4 study of Bone Loss and Change in Bone Mineral Density, is actively recruiting participants, sponsored by Insud Pharma.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,710 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Measured by dual-energy X-ray absorptiometry (DXA)
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 |
What NCT05303636 shows while recruiting
NCT05303636 is an interventional study that assigns participants to a tested intervention. Its 1,710 participants enrollment target places it among the larger protocols in the corpus, above the 148-participant average among 16 other Bone Loss trials with a reported enrollment target (1055% higher).
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.
NCT05303636 names 20 study sites across 11 states, led by Florida, Texas, Louisiana.
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.
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).
Who is sponsoring clinical trial NCT05303636?
This trial is sponsored by Insud Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05303636's enrollment target sits among peer trials
1,710 1st of 16 higher than 16 of 16 other Bone Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bone Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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