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.
Conditions
Interventions
Trade Name: Jaydess
Pharmaceutical Form: Intrauterine delivery system
Sponsors
University Hospital of North Norway
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal of the present study is to investigate the effect of the levonorgestrel impregnated intrauterine system (LNG-IUS) Jaydess (12mikrog/24t) as therapy for endometrial hyperplasia and for endometrial hyperplastic polyps. Traditionally hysterectomy has been preferred as treatment for complex atypical hyperplasia. Oral use of progestogens has been used as routine therapy for endometrial hyperplasia not selected for surgery, but former studies have shown too much variation in dose, treatment time, progestational agent and mode of distribution to be comparable and provide a basis for consensus for therapy. Thus, no professional guidelines really exist. Over the past 30 years LNG-IUS has been introduced as alternative therapy for endometrial hyperplasia. In an recent multicenter RCT comparing oral progestin and LNG-IUS Mirena (20mikrog/24 t), the latter showed superior effect and 100% therapy response was obtained after six months treatment time. ;Secondary Objective: Jaydess is releasing less hormone than Mirena and has a smaller T-frame and smaller tube for insertion. Secondary objectives are adverse effects and ease of administration with Jaydess compared to Mirena. ;Primary end point(s): Treatment respons with abcence of endometrial hyperplasia/hyperplastic polyps or persisting endometrial hyperplasia/hyperplastic polyps assessed by light microscopy. ;Timepoint(s) of evaluation of this end point: Study group a: After 6 months of treatment Study group b: After 4 - 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ease of administration, adverse effects.;Timepoint(s) of evaluation of this end point: Study group a: After 6 months of treatment Study group b: After 4 - 6 weeks There will not be any planned consultations during the treatment periode, but patients will receive thorough information about who to contact if adverse events occurs. | — |
Countries
Norway
Contacts
Public ContactClinical Research Department
University Hospital of North Norway
Outcome results
None listed