BridgeMD
A multicenter, open-label, controlled study to investigate the effect of either LF111 or Drospirenone chewable tablets on bone mineral density (BMD) in adolescent and adult women in comparison with non-users of hormonal contraceptive methods.
EU CTIS ID: 2024-512347-23-00
What this study is testing
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
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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 a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
- 2. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg at Visit 1, in sitting position after 5 minutes of rest.
- 3. Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant)
- 4. Be able and willing to provide written informed consent, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures.
- 5. Willing to use trial contraception for thirteen 28-day cycles (LF111 arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively.
You likely can't join if
- 1. Contraindications to the use of LF111 (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 LF111 arm only).
- 10. Eating disorders (e.g., anorexia nervosa, bulimia).
- 11. Celiac disease.
- 12. Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease).
- 13. Rheumatoid arthritis.
- 14. Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium.
See the full eligibility criteria
Who can join
- 1. 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 a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
- 2. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg at Visit 1, in sitting position after 5 minutes of rest.
- 3. Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant)
- 4. Be able and willing to provide written informed consent, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures.
- 5. Willing to use trial contraception for thirteen 28-day cycles (LF111 arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively.
What rules you out
- 1. Contraindications to the use of LF111 (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 LF111 arm only).
- 10. Eating disorders (e.g., anorexia nervosa, bulimia).
- 11. Celiac disease.
- 12. Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease).
- 13. Rheumatoid arthritis.
- 14. Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium.
- 15. Treatment with medications that are known to decrease bone mass: • Glucocorticoids (oral, intravenous, chronic inhaled or 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 consecutive 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.
- 16. 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.
- 17. Any condition that, in the opinion of the investigator, may jeopardize the trial conduct according to the protocol.
- 18. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- 2. BMD Z-score below -1.50 at any anatomic location. 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.
- 3. 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.
- 4. Medical conditions associated with low bone mass: a. Metabolic bone disease such as osteogenesis imperfecta, Paget's disease of the bone, osteomalacia/rickets b. Collagen vascular diseases such as Marfan's syndrome and Erhlos- Danlos syndrome c. 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 d. Gastrointestinal (malabsorptive) disease including inflammatory bowel disease, gastric bypass surgery and current postgasrectomy syndrome e. Liver disease f. Abnormal bone mineral metabolism (hypocalcemia/hypercalcemia, hypophosphatemia/hyperphosphatemia, hypomagnesemia).
- 5. In adolescents only: Short stature defined as height-for-age percentile less than the fifth percentile.
- 6. Use of oral, transdermal, vaginal or intrauterine hormonal contraceptives in the previous month (within the previous 3 months in case of containing estrogen) or use of injectable or implantable hormonal contraceptives in the previous 6 months.
- 7. 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.
- 8. Ongoing pregnancy or wish for pregnancy.
- 9. Currently lactating or stopped lactating within the past year.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.