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Progestin
Hormonal Contraceptives' Impact on Bone Density
Phase 4
Waitlist Available
Research Sponsored by Insud Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects with regular menstrual cycles (postmenarcheal for at least two years and premenopausal) aged 14 to 45 years.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months and to 12 months
Awards & highlights
Summary
This trial will compare the effects of a hormonal contraceptive to non-hormonal methods on bone density over the course of a year.
Eligible Conditions
- Osteoporosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are eligible for contraceptive services.
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You are female and have regular menstrual cycles.
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You are a woman and you have not had a pregnancy in the last 6 months.
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You are willing to use a contraceptive method 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months and to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months and to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Mean absolute change in lumbar spine (L1-L4) Z-score in adolescents
Cohort 2: Mean percentage change in lumbar spine (L1-L4) BMD in adults
Secondary outcome measures
Changes in body weight and body mass index (BMI)
Cohort 1: Mean absolute and percentage changes in TBLH bone mineral content (BMC) in adolescents
Cohort 1: Mean absolute and percentage changes in lumbar spine, femoral neck, total hip, and TBLH BMD in adolescents
+13 moreOther outcome measures
Changes in body fat and lean mass
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2 (adults aged 18-45) Hormonal Treatment ArmExperimental Treatment1 Intervention
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.
Group II: Cohort 1 (adolescents aged 14-17) Hormonal Treatment ArmExperimental Treatment1 Intervention
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.
Group III: Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive ArmActive Control1 Intervention
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.
Group IV: Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method ArmActive Control1 Intervention
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.
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Who is running the clinical trial?
Insud PharmaLead Sponsor
8 Previous Clinical Trials
22,590 Total Patients Enrolled
Chemo ResearchIndustry Sponsor
5 Previous Clinical Trials
3,191 Total Patients Enrolled
Enrico Colli, MDStudy DirectorChemo Research SL
3 Previous Clinical Trials
3,595 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently pregnant or planning to become pregnant.You are currently taking medications that can make your bones weaker.You have a medical condition that causes weak bones.You are currently taking certain medications that may interfere with the study, such as anticonvulsants, protease inhibitors, cyclosporine, heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitors (PPIs), or selective serotonin reuptake inhibitors (SSRIs).You have certain conditions that affect the connective tissues in your body, like Marfan syndrome or Ehlers-Danlos syndrome.You have experienced a bone fracture from a fall at a height of standing or less, excluding fractures in the fingers, toes, face, and skull.You have a digestive disorder that affects how your body absorbs nutrients, such as inflammatory bowel disease or a history of stomach surgery.You are eligible for contraceptive services.You are willing to use a contraceptive method 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 have rheumatoid arthritis.You are a woman and you have not had a pregnancy in the last 6 months.You have a hormone-related condition like diabetes or thyroid problems that is not well controlled, even with consistent treatment for more than 2 months.You have a bone disease like osteogenesis imperfecta, Paget's disease, or osteomalacia/rickets.You are currently taking or have ever taken medications or supplements that are known to increase bone density.You have taken aromatase inhibitors or raloxifene in the past two years.You have a condition called an eating disorder, like anorexia nervosa or bulimia.You are female and have regular menstrual cycles.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive Arm
- Group 2: Cohort 2 (adults aged 18-45) Hormonal Treatment Arm
- Group 3: Cohort 1 (adolescents aged 14-17) Hormonal Treatment Arm
- Group 4: Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method Arm
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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