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Birth control pills under scrutiny: do they weaken bones?

NCT ID NCT05303636

Knowledge-focused Sponsor: Insud Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether two types of hormonal birth control pills (LF111 and drospirenone) affect bone density in women aged 14 to 45. Over 1,500 participants will have their bone density measured after 12 months and compared to women using non-hormonal birth control. The goal is to understand any risks to bone health from these contraceptives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,536 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

14 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bone Diseases, Metabolic osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone loss Change in bone mineral density

Contacts and locations

Locations

  • Advanced Clinical Research Network

    Coral Gables, Florida, 33134, United States

  • BioMD Research

    Coral Gables, Florida, 33134, United States

  • CM Medyceusz, Apteka szpitalna

    Lodz, Poland

  • Centrum Bocian Sp Z O. O. Spólka Komandytowa

    Bialystok, Poland

  • Centrum Bocian Sp z o.o. Sp.

    Katowice, Poland

  • Centrum Medyczne Linden

    Krakow, Poland

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23510, United States

  • Clinical Trials Management, LLC - Southshore

    Metairie, Louisiana, 70006, United States

  • Cornerstone Research Institute

    Longwood, Florida, 32750, United States

  • D&H National Research Centers

    Miami, Florida, 33155, United States

  • Direct Helpers Research Center

    Hialeah, Florida, 33012, United States

  • Encore Medical Research of Boynton Beach LLC

    Boynton Beach, Florida, 33436, United States

  • Encore Medical Research of Weston LLC

    Weston, Florida, 33331, United States

  • Encore Medical Research, LLC

    Hollywood, Florida, 33021, United States

  • Felicidad Medical Research, LLC

    Miami, Florida, 33184, United States

  • Florida Pharmaceutical Research and Associates, Inc.

    South Miami, Florida, 33143, United States

  • Grazyna Bogutyn Medico Praktyka Lekarska

    Krakow, Poland

  • GynCentrum Sp. z o.o.

    Katowice, Poland

  • Health Care Family Rehab & Research Center

    Hialeah, Florida, 33015, United States

  • KM International Research Operation LLC

    Saint Cloud, Florida, 34769, United States

  • Klinika Leczenia Nieplodnosci, Ginekologii i Poloznictwa Bocian

    Warsaw, Poland

  • Lillestol Research LLC

    Fargo, North Dakota, 58104, United States

  • Lékárna Devetsil JST s.r.o.

    Slovany, Czechia

  • Lékárna U Zvonice

    Vysoké Mýto, Czechia

  • Meridian Clinical Research

    Norfolk, Nebraska, 68701, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • New Age Medical Research Corporation

    Miami, Florida, 33186, United States

  • OB/GYN Associates of Erie

    Erie, Pennsylvania, 16502, United States

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Seattle Clinical Research Center

    Seattle, Washington, 98105, United States

  • Signature Gyn Services

    Fort Worth, Texas, 76104, United States

  • TMC Life Research, Inc.

    Houston, Texas, 77054, United States

  • Tidewater Clinical Research, Inc.

    Norfolk, Virginia, 23502, United States

  • University of Colorado Denver - School of Medicine - Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Michigan C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48103, United States

  • Vita Longa Sp. z o.o.

    Katowice, Poland

  • Vital Pharma Research

    Hialeah, Florida, 33016, United States

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