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

Endometrial Hyperplasia Without Atypia Clinical Trial

Official title:

The Etonogestrel Contraceptive Implant for Treatment of Endometrial Hyperplasia Without Atypia: A Single-arm, Open-label, Longitudinal Study in a Government Hospital in the Philippines

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378489
• Other study ID #: 2022-0346-01
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: University of the Philippines
• Contact: Bernadette Ann S Alcazaren, MD
• Phone: 639178108864
• Email: bsalcazaren[@]up.edu.ph
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Endometrial Hyperplasia
• Endometrial Hyperplasia Without Atypia
• Hyperplasia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of the Philippines	Organon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of (resolution) regression to normal endometrium		3 months after the insertion of the implant
Primary	Endometrial thickness (by ultrasound)	Performed by expert sonologist	At three and six months after insertion of the implant