LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
NCT ID: NCT05303636
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1710 participants
INTERVENTIONAL
2022-03-28
2027-03-31
Brief Summary
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Detailed Description
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At Visit 1 (screening), informed consent/assent will be obtained, and the screening procedures will be performed. At Visit 2 (allocation to treatment), after confirming the subject's eligibility, subjects who choose to use LF111 or DRSP 3.5 mg chewable tablets (USA only) for pregnancy prevention will be provided with LF111 or DRSP 3.5 mg chewable tablets. The subjects will attend additional on-site visits 6 months and 12 months after Visit 2 (end of investigational phase) or within one week after premature trial discontinuation for routine safety assessments.
The primary objective of this study is to evaluate the impact of LF111 and 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
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Study Design
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NON_RANDOMIZED
FACTORIAL
SCREENING
NONE
Study Groups
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Cohort 1 (adolescents aged 14-17) Hormonal Treatment Arm
Subjects in the USA will choose to use the LF111 tablets or drospirenone (DRSP) 3.5 mg chewable tablets; 1/3 of subjects in the USA should receive DRSP 3.5 mg chewable tablets. Only LF111 will be available to subjects in Europe.
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.
Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive Arm
Subjects in this group will not receive any investigational product. They will be free to use a non-hormonal contraceptive method of their choice. Non-hormonal contraceptive methods include barrier contraceptive methods (condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), double barrier methods, non-hormonal IUD (e.g., copper IUD), surgical female sterilization, vasectomized partner, spermicides, and sexual abstinence.
No interventions assigned to this group
Cohort 2 (adults aged 18-45) Hormonal Treatment Arm
Subjects in the USA will choose to use the LF111 tablets or drospirenone (DRSP) 3.5 mg chewable tablets; 1/3 of subjects in the USA should receive DRSP 3.5 mg chewable tablets. Only LF111 will be available to subjects in Europe.
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.
Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method Arm
Subjects in this group will not receive any investigational product. They will be free to use a non-hormonal contraceptive method of their choice. Non-hormonal contraceptive methods include barrier contraceptive methods (condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), double barrier methods, non-hormonal IUD (e.g., copper IUD), surgical female sterilization, vasectomized partner, spermicides, and sexual abstinence.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
45 Years
FEMALE
Yes
Sponsors
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Chemo Research
INDUSTRY
Insud Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Enrico Colli, MD
Role: STUDY_DIRECTOR
Chemo Research SL
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ernesto Gomez, MD
Role: primary
Kevin O'Brien, MD
Role: primary
Gil Fernandez-Yera, MD
Role: primary
Jose Lopez
Role: primary
Rafael Garcia-Ocasio, MD
Role: primary
Michael Akpeke, MD
Role: primary
Janet Gersten, MD
Role: primary
Ana Roig-Cantisano, MD
Role: primary
Jamie S Ackerman
Role: primary
Stephen Blank, MD
Role: primary
Richard Radnovich, DO
Role: primary
Gary Reiss, MD
Role: primary
Allison Rodriguez, MD
Role: primary
Keith Vrbicky, MD
Role: primary
Pouru Bhiwandi, MD
Role: primary
Michael J Lillestol, MD
Role: primary
Charles Kirkham, MD
Role: primary
John Whitfield, MD
Role: primary
Mark Jacobs, MD
Role: primary
Rebecca Dunsmoor-Su, MD
Role: primary
References
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Rosenbaum P, Schmidt W, Helmerhorst FM, Wuttke W, Rossmanith W, Freundl F, Thomas K, Grillo M, Wolf A, Heithecker R. Inhibition of ovulation by a novel progestogen (drospirenone) alone or in combination with ethinylestradiol. Eur J Contracept Reprod Health Care. 2000 Mar;5(1):16-24. doi: 10.1080/13625180008500376.
Cibula D, Skrenkova J, Hill M, Stepan JJ. Low-dose estrogen combined oral contraceptives may negatively influence physiological bone mineral density acquisition during adolescence. Eur J Endocrinol. 2012 Jun;166(6):1003-11. doi: 10.1530/EJE-11-1047. Epub 2012 Mar 21.
Beksinska ME, Smit JA. Hormonal contraception and bone mineral density. Expert Rev of Obstet Gynecol. 2011;6(3);305-319.
Weaver CM, Gordon CM, Janz KF, Kalkwarf HJ, Lappe JM, Lewis R, O'Karma M, Wallace TC, Zemel BS. The National Osteoporosis Foundation's position statement on peak bone mass development and lifestyle factors: a systematic review and implementation recommendations. Osteoporos Int. 2016 Apr;27(4):1281-1386. doi: 10.1007/s00198-015-3440-3. Epub 2016 Feb 8.
Rizzo ADCB, Goldberg TBL, Biason TP, Kurokawa CS, Silva CCD, Corrente JE, Nunes HRC. One-year adolescent bone mineral density and bone formation marker changes through the use or lack of use of combined hormonal contraceptives. J Pediatr (Rio J). 2019 Sep-Oct;95(5):567-574. doi: 10.1016/j.jped.2018.05.011. Epub 2018 Jun 28.
Schwartz GJ, Munoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.
Pierce CB, Munoz A, Ng DK, Warady BA, Furth SL, Schwartz GJ. Age- and sex-dependent clinical equations to estimate glomerular filtration rates in children and young adults with chronic kidney disease. Kidney Int. 2021 Apr;99(4):948-956. doi: 10.1016/j.kint.2020.10.047. Epub 2020 Dec 8.
Carr B, Dmowski WP, O'Brien C, Jiang P, Burke J, Jimenez R, Garner E, Chwalisz K. Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone acetate for the treatment of endometriosis: effects on bone mineral density. Reprod Sci. 2014 Nov;21(11):1341-51. doi: 10.1177/1933719114549848. Epub 2014 Sep 23.
Other Identifiers
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2020-000412-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LF111/401
Identifier Type: -
Identifier Source: org_study_id
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