The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study

NCT ID: NCT06378489

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-05-31

Brief Summary

Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).

The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant.

Conditions

Endometrial Hyperplasia Without Atypia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Etonogestrel implant

The etonogestrel implant will be inserted on the inner side of the non-dominant upper arm of the patient. Three months after insertion, a repeat transvaginal ultrasound will be performed to document endmetrial thickness and an endometrial biopsy will also be done using the Pipelle to document the histology of the endometrium. If the biopsy showed regression of the hyperplasia, the implant will be left in place for a minimum of 12 months until 3 years. If the repeat biopsy showed non-resolution of the hyperplasia, the patient will be referred to a gynecologic oncologist for further management

Intervention Type: DRUG

Other Intervention Names

Implanon NXT

Eligibility Criteria

Inclusion Criteria

• women aged 18 years old to perimenopause who present with or without abnormal uterine bleeding and who have an endometrial biopsy result which shows endometrial hyperplasia without atypia
• women willing to have the etonogestrel implant (Implant NXT) for the duration of treatment (6-12 months)
• women who wish to retain their uterus

Exclusion Criteria

-

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

Sponsors

Organon

INDUSTRY

Sponsor Role: collaborator

University of the Philippines

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Jose D Padilla, MD

Role: PRINCIPAL_INVESTIGATOR

Philippine General Hospital

Central Contacts

Bernadette Ann S Alcazaren, MD

Role: CONTACT

bsalcazaren@up.edu.ph

639178108864

Other Identifiers

2022-0346-01

Identifier Type: -

Identifier Source: org_study_id