An observational study in Endometrial Hyperplasia Without Atypia, sponsored by University of the Philippines. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by University of the Philippines · Observational
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.
110 studies on the registry are indexed under Endometrial Hyperplasia; 38 are open to participants now.
This study's planned enrollment of 60 is below the median of 125 across 32 observational studies indexed under Endometrial Hyperplasia.
Browse Endometrial Hyperplasia studies →University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Implanon NXT
Rate of (resolution) regression to normal endometrium
Time frame: 3 months after the insertion of the implant
Endometrial thickness (by ultrasound)
Performed by expert sonologist
Time frame: At three and six months after insertion of the implant
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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University of the Philippines