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Progestin

Levonorgestrel Drug Implant for Endometrial Hyperplasia

Phase 3
Waitlist Available
Led By Janelle Darby, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights

Study Summary

This trial is comparing two treatments for endometrial hyperplasia to see which is more effective.

Eligible Conditions
  • Endometrial Hyperplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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
Histologic Response Scoring of Biopsy Specimens
Secondary outcome measures
Number of Toxicities for Each Treatment
Pathological Response to Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Levonorgestrel IUD - Comparison ArmExperimental Treatment1 Intervention
Levonorgestrel intrauterine device with 52 mg progestin (Releases 20mcg/daily)
Group II: Megestrol Acetate Arm - Control ArmActive Control1 Intervention
Megestrol Acetate 160 mg by mouth daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levonorgestrel Drug Implant
2018
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,237 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,489 Total Patients Enrolled
10 Trials studying Endometrial Hyperplasia
2,115 Patients Enrolled for Endometrial Hyperplasia
Janelle Darby, MDPrincipal InvestigatorWake Forest Baptist Health Sciences

Frequently Asked Questions

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

What common conditions does the Levonorgestrel Drug Implant help with?

"Women who have had children, endometrial hyperplasia, and acquired immunodeficiency syndrome can all be treated with Levonorgestrel Drug Implant."

Answered by AI

The FDA has given their okay to Levonorgestrel drug implants, correct?

"There is some evidence to support the efficacy of Levonorgestrel as well as multiple rounds of data that suggest it is safe, so our team at Power gave it a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia
2023. "Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04897217.
~0 spots leftby Oct 2024
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