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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
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Osteoporosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
Select...
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 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months and to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months and to 12 months for reporting.

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 more
Other outcome measures
Changes in body fat and lean mass

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.

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.

Find a Location

Who is running the clinical trial?

Insud PharmaLead Sponsor
7 Previous Clinical Trials
2,590 Total Patients Enrolled
Chemo ResearchIndustry Sponsor
4 Previous Clinical Trials
2,971 Total Patients Enrolled
Enrico Colli, MDStudy DirectorChemo Research SL
3 Previous Clinical Trials
3,595 Total Patients Enrolled

Media Library

Drospirenone (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT05303636 — Phase 4
Osteoporosis Research Study Groups: Cohort 1 (adolescents aged 14-17) Hormonal Treatment Arm, Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive Arm, Cohort 2 (adults aged 18-45) Hormonal Treatment Arm, Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method Arm
Osteoporosis Clinical Trial 2023: Drospirenone Highlights & Side Effects. Trial Name: NCT05303636 — Phase 4
Drospirenone (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05303636 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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)"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
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~939 spots leftby Jul 2026