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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 13 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have stopped having your period for no clear reason.You have had trouble getting pregnant in the past.You have been diagnosed with polycystic ovary syndrome (PCOS).
Research Study Groups:
This trial has the following groups:- Group 1: LPRI424
Awards:
This trial has 4 awards, including:- 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.
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.