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Hormonal Contraceptives' Impact on Bone Density
Study Summary
This trial will compare the effects of a hormonal contraceptive to non-hormonal methods on bone density over the course of a year.
- Osteoporosis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- 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.
- 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.
Frequently Asked Questions
Is it permissible for me to participate in this clinical exploration?
"This research study is looking for 1710 people with alopecia, aged between 14 and 45 years old. To be considered eligible, candidates must satisfy the following criteria; have appropriate permission from their local government to receive contraceptive services, a systolic blood pressure of less than 130 mmHg while seated after 5 minutes rest, demonstrate willingness to provide written consent or assent if they are a minor, female participants should have had regular menstrual cycles for two years plus since menarche and not be pregnant in the past 6 months (if applicable), agree to use trial contraception during 13 28-day cycles (LF111 arm)"
Are there numerous health care facilities conducting this research within the US?
"19 clinical trials sites have been identified for this study, including University of Florida - Jacksonville in Jacksonville, Meridian Clinical Research - Norfolk in Norfolk and Tandem Clinical Research in Marrero."
What objectives is this experiment seeking to fulfill?
"According to the information provided by Insud Pharma, this trial will be measuring a primary outcome of Mean absolute change in lumbar spine (L1-L4) Z-score over Baseline to 12 months. In addition, secondary outcomes including Mean absolute changes in Z-scores (femoral neck, total hip, and total body less head [TBLH]), mean absolute and percentage changes in BMD (lumber spine, femoral neck, total hip and TBLH), as well as proportion of adolescent subjects with percentage changes in lumber spine etc., are also being evaluated."
How many participants are there in this experiment?
"This clinical trial requires 1710 individuals who meet the set criteria to be enrolled. The University of Florida - Jacksonville in Jacksonville, FL and Meridian Clinical Research - Norfolk in Norfolk, NE are two of several available locations for participation."
Is this research initiative accepting participants above the age of fifty?
"As outlined in the study's criteria, individuals between 14 and 45 years old are eligible to participate."
What sort of risks does LF111 (drospirenone) pose to human health?
"The safety of LF111 (drospirenone) was appraised a 3 due to it being approved as part of a Phase 4 trial."
Are there any openings for participation in this experiment?
"According to the clinicaltrials.gov website, this research endeavor is still in need of participants. It was published on March 28th 2022 and had its most recent updates made at the end of June 2021."
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