Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia

NCT ID: NCT04897217

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2026-11-30

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.

Conditions

Endometrial Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Megestrol Acetate Arm - Control Arm

Megestrol Acetate 160 mg by mouth daily

Group Type: ACTIVE_COMPARATOR

Megestrol Acetate

Intervention Type: DRUG

The control arm will consist of oral progesterone therapy (megestrol acetate 160mg po daily). The intervention will be administered on an outpatient basis.

Levonorgestrel IUD - Comparison Arm

Levonorgestrel intrauterine device with 52 mg progestin (Releases 20mcg/daily)

Group Type: EXPERIMENTAL

Levonorgestrel Drug Implant

Intervention Type: DRUG

Participants in the comparison arm will have a levonorgestrel intrauterine device placed in the office or in the operating room if the office procedure not tolerated or if they have not had a prior dilation and curettage.

Interventions

Megestrol Acetate

The control arm will consist of oral progesterone therapy (megestrol acetate 160mg po daily). The intervention will be administered on an outpatient basis.

Intervention Type: DRUG

Levonorgestrel Drug Implant

Participants in the comparison arm will have a levonorgestrel intrauterine device placed in the office or in the operating room if the office procedure not tolerated or if they have not had a prior dilation and curettage.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janelle Darby, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Health Sciences

Other Identifiers

WFBCCC 99321

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00074615

Identifier Type: -

Identifier Source: org_study_id