Effects of hormonal intrauterine system (Jaydess) in treatment of precursor lesions to endometrial cancer

• Conditions: Endometrial cancer has presently become the most frequent gynaecologic malinancy in the Western World and the incidence is still increasing. In Norway a 50% increase in occurence has been observed over the last ten years. Because endometrial hyperplasia represents precursor lesions to endometrial cancer it seems likely that adequate therapy for preliminary stages would contribute to reducing the rapid increase in endometrial cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000612-17-NO
• Lead Sponsor: niversity Hospital of North Norway

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-25
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Histologically proven endometrial hyperplasia or hyperplastic endometrial polyps according to WHO94 classification and D-score
-Study group a: D-score = 0.
Study group b: D-score ‹ 0
-Women age = 25 and = 80 years
-No contraindications for gestagene hormone

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Suspicion of endometrial carcinoma
-Age ‹ 25 years or › 80 years
-Pregnancy
-Acute or chronic pelvic inflammatory disease (PID)
-Postpartum endometritis or infections in the genital tract aften abortion during the last 3 months
-Cervical intraepitelial neoplasia
-Malignancy in uterus or cervix
-Breast cancer history
-Undiagnosed vaginal bleeding
-Congenital or aquried uterin anomali, including myomas
-Liverdisease or livertumor
-Thrombophlebitis
-Earlier adverse reactions to progestogen
-Any reason why, in the opinion of the investigator, the patient should not participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified