Clinical trial NCT06378489: The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Endometrial Hyperplasia Without Atypia
Keywords: endometrial hyperplasia without atypia
etonogestrel implant
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2024-04-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


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:

-

Primary outcomes:
measure: Rate of (resolution) regression to normal endometrium
timeFrame: 3 months after the insertion of the implant
measure: Endometrial thickness (by ultrasound)
timeFrame: At three and six months after insertion of the implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Philippine General Hospital
name: Patrick Jose D Padilla, MD
role: PRINCIPAL_INVESTIGATOR
References: