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Hormone Therapy

A Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, and Tolerability of LPRI-424, 13 Cycles

Phase 3
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests a new contraceptive called LPRI424 in females who want birth control. It aims to see how well it prevents pregnancy and how safe it is. The contraceptive likely works by stopping egg release, blocking sperm, or preventing egg attachment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of pregnancies (evaluable cycles)
Secondary study objectives
Number of participants with adverse events as a measure of safety
Number of pregnancies (all)
Number of pregnancies (method failures)
+4 more

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LPRI424Experimental Treatment1 Intervention
Dienogest 2 mg / ethinyl estradiol 0.02 mg tablet orally once daily for 24 days followed by 4 placebo tablets for a 28 day cycle, for 13 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethinylestradiol
FDA approved

Find a Location

Who is running the clinical trial?

Insud PharmaLead Sponsor
8 Previous Clinical Trials
23,266 Total Patients Enrolled
Chemo ResearchIndustry Sponsor
5 Previous Clinical Trials
3,867 Total Patients Enrolled
Enrico Colli, MDStudy DirectorChemo Research
3 Previous Clinical Trials
4,271 Total Patients Enrolled

Media Library

LPRI424 (dienogest/ethinylestradiol) (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03945513 — Phase 3
Birth Control Research Study Groups: LPRI424
Birth Control Clinical Trial 2023: LPRI424 (dienogest/ethinylestradiol) Highlights & Side Effects. Trial Name: NCT03945513 — Phase 3
LPRI424 (dienogest/ethinylestradiol) (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03945513 — Phase 3
~172 spots leftby Dec 2025