Clinical trial NCT04897217: Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia
Official title: Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia: A Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Endometrial Hyperplasia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 megestrol acetate to treat their hyperplasia. While both methods are commonly used in practice, investigators would like to see what effects each treatment has on uterine tissue.

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 months after randomization. Non-inferiority analysis.

Secondary Objective(s):

* To determine the safety of each treatment modality.
* Determine the feasibility of transvaginal ultrasound to predict treatment response.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Histologic Response Scoring of Biopsy Specimens
timeFrame: 6 months
Secondary outcomes:
measure: Number of Toxicities for Each Treatment
timeFrame: Up to 8 months
measure: Pathological Response to Treatment
timeFrame: Up to 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest Baptist Health Sciences
name: Janelle Darby, MD
role: PRINCIPAL_INVESTIGATOR
References: