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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

A Multicenter, Open-label, Controlled Study to Investigate the Effect of Either LF111 or Drospirenone Chewable Tablets on Bone Mineral Density in Adolescent and Adult Women in Comparison With Non-users of Hormonal Contraceptive Methods

LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women (NCT05303636) is a Phase 4 interventional studying Change in Bone Mineral Density and Bone Loss, sponsored by Insud Pharma. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 1,710 participants makes this one of the larger Change in Bone Mineral Density trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: - Female subjects with regular menstrual cycles (postmenarcheal for at least two years and premenopausal) aged 14 to 45 years. - Female subjects aged between 14 to 17 years (inclusive) will only be included provided that: - Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and - All applicable laws and regulations regarding the willing to sign a consent form/assent of the subjects to participate in clinical trials are observed. - Systolic blood pressure \< 140 mmHg, diastolic blood pressure \< 90 mmHg at Visit 1, in sitting position after 5 minutes of rest. - Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant). - Be able and willing to provide written willing to sign a consent form, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures. - Willing to use trial contraception for thirteen 28-day cycles (hormonal treatment arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively. Who Should NOT Join This Trial: - Contraindications to the use of LF111 or DRSP 3.5 mg chewable tablets (such as active arterial or venous thromboembolic disorders, liver tumors benign or malignant, hepatic impairment, renal impairment, adrenal insufficiency, presence or history of cervical cancer or progestin-sensitive cancers, known or suspected sex-steroid sensitive malignancies, undiagnosed abnormal uterine bleeding, undiagnosed vaginal bleeding, hypersensitivity to active substance or excipient) or adverse effects due to previous contraceptive use (for the hormonal treatment arm only). - BMD Z-score below -1.50. The TBLH Z-score applies only to Cohort 1 (adolescents) and the total body Z-score applies only to Cohort 2 (adults) when assessing study eligibility. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Female subjects with regular menstrual cycles (postmenarcheal for at least two years and premenopausal) aged 14 to 45 years. * Female subjects aged between 14 to 17 years (inclusive) will only be included provided that: * Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and * All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. * Systolic blood pressure \< 140 mmHg, diastolic blood pressure \< 90 mmHg at Visit 1, in sitting position after 5 minutes of rest. * Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant). * Be able and willing to provide written informed consent, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures. * Willing to use trial contraception for thirteen 28-day cycles (hormonal treatment arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively. Exclusion Criteria: * Contraindications to the use of LF111 or DRSP 3.5 mg chewable tablets (such as active arterial or venous thromboembolic disorders, liver tumors benign or malignant, hepatic impairment, renal impairment, adrenal insufficiency, presence or history of cervical cancer or progestin-sensitive cancers, known or suspected sex-steroid sensitive malignancies, undiagnosed abnormal uterine bleeding, undiagnosed vaginal bleeding, hypersensitivity to active substance or excipient) or adverse effects due to previous contraceptive use (for the hormonal treatment arm only). * BMD Z-score below -1.50. The TBLH Z-score applies only to Cohort 1 (adolescents) and the total body Z-score applies only to Cohort 2 (adults) when assessing study eligibility. * Low trauma fracture(s) defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face, and skull. * Medical conditions associated with low bone mass: * Metabolic bone disease such as osteogenesis imperfecta, Paget's disease of the bone, osteomalacia/rickets. * Collagen vascular diseases such as Marfan syndrome and Ehlers-Danlos syndrome. * Chronic kidney disease stage 3 with estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 using the Bedside Schwartz equation for adolescents and the Modification of Diet in Renal Disease (MDRD) method for adult subjects. * Gastrointestinal (malabsorptive) disease including inflammatory bowel disease, gastric bypass surgery and current post-gastrectomy syndrome. * Liver disease. * Abnormal bone mineral metabolism (hypocalcemia/hypercalcemia, hypophosphatemia/hyperphosphatemia, hypomagnesemia). * In adolescents only: Short stature defined as height-for-age percentile less than the fifth percentile. * Use of progestin-only contraceptive pills in the previous month or use of implantable hormonal contraceptives in the previous 6 months. * Laboratory values at screening which are considered clinically significant and which in the opinion of the investigator would be detrimental for participation in the study. * Ongoing pregnancy or wish for pregnancy. * Currently lactating or stopped lactating within the last 12 months. * Eating disorders (e.g., anorexia nervosa, bulimia). * Celiac disease. * Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease) not adequately controlled with a stable treatment regiment for \> 2 months. * Rheumatoid arthritis. * Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium. * Treatment with medications that are known to decrease bone mass: * Glucocorticoids (oral, intravenous, chronic inhaled, chronic extensive topical \[\> 3 months\]) within the previous 3 months. Note: Subjects taking chronic oral/intravenous glucocorticoids (prednisone ≥ 2.5 mg daily for ≥ 3 months, or the equivalent) will have a washout period of 12 months. * Depo-medroxyprogesterone acetate within the previous 24 months (if duration of use was less than 2 consecutive years). Note: Subjects using depo-medroxyprogesterone acetate for a duration of use greater than 2 years will be excluded. * Aromatase inhibitors and/or raloxifene within the previous 24 months. * Anticonvulsants (phenytoin, phenobarbital, carbamazepine and valproate), anti-retroviral protease inhibitors, cyclosporine, heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitor (PPI) use (\> 3 months), or selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months. * Conditions that preclude BMD measurement i.e. lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring (not willing to remove) or weight that exceeds the DXA machine limitation. * Any condition that, in the opinion of the investigator, may jeopardize the trial conduct according to the protocol. * Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.

Treatments Being Tested

DRUG

LF111 (drospirenone 4 mg oral tablet) or drospirenone (DRSP) 3.5 mg chewable tablet

LF111 (drospirenone 4 mg tablet orally daily on days 1-24, followed by placebo tablet orally daily on days 25-28) or drospirenone (DRSP) 3.5 mg chewable tablet chewed daily on days 1-24, followed by placebo tablet chewed daily on days 25-28) (USA only). Subjects in the USA who choose to use the hormonal contraceptive method may choose between LF111 and DRSP 3.5 mg chewable tablets. The DRSP 3.5 mg chewable tablets are not available to subjects in Europe. Subjects in Europe who choose to use the hormonal contraceptive method will only receive LF111.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cactus Clinical Research, Inc.
Phoenix, Arizona, United States
Velocity Clinical Research
Denver, Colorado, United States
Advanced Clinical Research Network
Coral Gables, Florida, United States
Health Care Family Rehab & Research Center
Hialeah, Florida, United States
Vital Pharma Research
Hialeah, Florida, United States
Cornerstone Research Institute
Longwood, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
Florida Pharmaceutical Research and Associates, Inc.
South Miami, Florida, United States
Comprehensive Clinical Research, LLC
West Palm Beach, Florida, United States
M3 Wake Research, Inc.
Sandy Springs, Georgia, United States
Family Care Research
Boise, Idaho, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Clinical Trials Management, LLC - Southshore
Metairie, Louisiana, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
M3 Wake Research
Raleigh, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Corpus Christi Women's Clinic
Corpus Christi, Texas, United States
Signature Gyn Services
Fort Worth, Texas, United States
TMC Life Research, Inc.
Houston, Texas, United States
Seattle Clinical Research Center
Seattle, Washington, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05303636), the sponsor (Insud Pharma), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05303636 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05303636?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05303636?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05303636. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05303636. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.