LF111 (drospirenone) for Osteoporosis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Osteoporosis+1 MoreLF111 (drospirenone) - Drug
Eligibility
14 - 45
Female
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: Baseline to 6 months (LF111 arm only) and to 12 months

Baseline to 12 months
Body lean and fat mass distribution
Changes in body weight and body mass index (BMI)
Cohort 1: Mean absolute change in lumbar spine (L1-L4) Z-score (adolescents)
Cohort 1: Proportion of adolescent subjects with percentage changes in lumbar spine, femoral neck, total hip, and TBLH BMD by categories
Cohort 2: Mean absolute and percentage changes in BMD (femoral neck, total hip, and total body) in adults
Cohort 2: Mean absolute changes in lumbar spine BMD in adults
Cohort 2: Mean percentage change in lumbar spine BMD in adults (aged 18-45)
Cohort 2: Proportion of adult subjects with percentage changes in lumbar spine, femoral neck, total hip, and total body BMD by categories
Baseline to 6 months
Cohort 1: Mean absolute changes in lumbar spine Z-score in adolescents (LF111 arm only)
Cohort 2: Mean absolute and percentage changes in BMD (lumbar spine, femoral neck, total hip, and total body) in adults (LF111 arm only)
Month 12
Cohort 1: Mean absolute and percentage changes in BMD (lumbar spine, femoral neck, total hip, and TBLH) in adolescents
Cohort 1: Mean absolute and percentage changes in TBLH bone mineral content (BMC) in adolescents
Cohort 1: Mean absolute changes in Z-scores (femoral neck, total hip, and total body less head [TBLH]) in adolescents
Cohort 1: Proportion of adolescent subjects with absolute changes in Z-scores (lumbar spine, femoral neck, total hip, and TBLH) by categories
Cohort 2: Mean absolute changes in Z-scores (lumbar spine, femoral neck, total hip, and total body) in adults
Cohort 2: Proportion of adult subjects with absolute changes in Z-scores (lumbar spine, femoral neck, total hip, and total body) by categories
Month 12
Routine laboratory values
Serum estradiol (E2) levels in the LF111 arm
Month 12
Number of subjects with adverse events as a measure of safety

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Drospirenone 4mg
5%Headache
5%Metrorrhagia
4%Dysmenorrhoea
4%Nausea
4%Breast pain
3%Acne
3%Breast tenderness
2%Weight increased
2%Menorrhagia
1%Amenorrhoea
1%Libido decreased
1%Abdominal pain
1%Vomiting
1%Abdominal distension
1%Menstruation irregular
1%Vulvovaginal mycotic infection
1%Decreased appetite
1%Mood swings
1%Affect lability
1%Vaginal haemorrhage
1%Migraine
1%Alopecia
1%Depression
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02269241) in the Drospirenone 4mg ARM group. Side effects include: Headache with 5%, Metrorrhagia with 5%, Dysmenorrhoea with 4%, Nausea with 4%, Breast pain with 4%.

Trial Design

4 Treatment Groups

Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive Arm
1 of 4
Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method Arm
1 of 4
Cohort 1 (adolescents aged 14-17) LF111 (drospirenone) Arm
1 of 4
Cohort 2 (adults aged 18-45) LF111 (drospirenone) Arm
1 of 4

Active Control

Experimental Treatment

1710 Total Participants · 4 Treatment Groups

Primary Treatment: LF111 (drospirenone) · No Placebo Group · Phase 4

Cohort 1 (adolescents aged 14-17) LF111 (drospirenone) Arm
Drug
Experimental Group · 1 Intervention: LF111 (drospirenone) · Intervention Types: Drug
Cohort 2 (adults aged 18-45) LF111 (drospirenone) Arm
Drug
Experimental Group · 1 Intervention: LF111 (drospirenone) · Intervention Types: Drug
Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive ArmNoIntervention Group · 1 Intervention: Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive Arm · Intervention Types:
Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method ArmNoIntervention Group · 1 Intervention: Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method Arm · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LF111 (drospirenone)
2014
Completed Phase 3
~1560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months (lf111 arm only) and to 12 months

Who is running the clinical trial?

Chemo ResearchIndustry Sponsor
2 Previous Clinical Trials
2,043 Total Patients Enrolled
Insud PharmaLead Sponsor
6 Previous Clinical Trials
2,327 Total Patients Enrolled
Enrico Colli, MDStudy DirectorChemo Research SL
3 Previous Clinical Trials
3,595 Total Patients Enrolled

Eligibility Criteria

Age 14 - 45 · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are eligible for contraceptive services.
You are female and have regular menstrual cycles.
You are a woman and you have not had a pregnancy in the last 6 months.
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.
All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
References