Status:
WITHDRAWN
Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Endometrial Hyperplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to compare the uterus tissue of women who receive an intrauterine system to treat their endometrial hyperplasia with the uterine tissue of women who receive meges...
Detailed Description
Primary Objective: To determine if Levonorgestrel-releasing intrauterine system is of equal efficacy to the standard systemic progestin therapy (megestrol acetate) based on endometrial sampling at 6 m...
Eligibility Criteria
Inclusion
- Complex atypical endometrial hyperplasia only. Confirmed by pathology report.
- Normal renal function and liver function tests.
- Age 18 or older.
- The effects of megestrol acetate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because megestrol acetate is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion
- Prior complex atypical endometrial hyperplasia or carcinoma.
- Prior hormone sensitive malignancy.\]
- Exogenous estrogen or progestin use presently or within the past 12 months.
- Standard contraindications to progestin therapy.
- Standard contraindications to intrauterine device use.
- Simple hyperplasia, complex hyperplasia without atypia (may be present in addition to atypical endometrial hyperplasia).
- Endometrial carcinoma (worrisome or possible carcinoma not exclusionary but requires dilatation and curettage if based only on office biopsy).
- Pregnant women are excluded from this study because megestrol acetate has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with megestrol acetate, breastfeeding should be discontinued if the mother is treated with megestrol acetate.
Key Trial Info
Start Date :
June 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04897217
Start Date
June 30 2023
End Date
November 1 2026
Last Update
July 5 2023
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