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Hormone Therapy

LPRI424 (dienogest/ethinylestradiol) for Birth Control

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

Study Summary

This trial is testing a new contraceptive drug to see if it is effective and safe.

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

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

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
4 Previous Clinical Trials
3,647 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

Frequently Asked Questions

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

What are the main reasons a doctor would prescribe LPRI424 (dienogest/ethinylestradiol)?

"LPRI424 (dienogest/ethinylestradiol) can be used to manage mild to moderate acne, premenstrual dysphoric disorder, and menopause."

Answered by AI

Does this experiment involve any geriatric patients?

"The minimum age for participation in this clinical trial is 15 and the maximum age is 45, as specified in the inclusion criteria."

Answered by AI

What other research has included LPRI424 (dienogest/ethinylestradiol) in their investigations?

"LPRI424 (dienogest/ethinylestradiol) is being trialed in 17 different locations. Out of the 17 clinical trials, 2 have progressed to Phase 3. Although the majority of research is being conducted in Savannah, Georgia, there are other locations running similar trials."

Answered by AI

Who is this study most likely to benefit?

"Eligible participants for this research should be using some form of contraception and between the ages of 15-45. This particular clinical trial is looking for around 1034 individuals."

Answered by AI

Are there documented risks associated with the use of LPRI424 (dienogest/ethinylestradiol)?

"LPRI424 (dienogest/ethinylestradiol) is a medication that has been studied in Phase 3 clinical trials. This denotes that while there is some evidence of efficacy, multiple rounds of data have gone into supporting its safety. Our team rates it as a 3."

Answered by AI
~197 spots leftby Mar 2025