E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
|
E.1.1.1 | Medical condition in easily understood language |
Cancer in the mucosa of the uterus (endometrial cancer) is the most common gynaecologic malinancy among women. Precursor lesions in the uterine mucosa is called endometrial hyperplasia. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Treatment respons with abcence of endometrial hyperplasia/hyperplastic polyps or persisting endometrial hyperplasia/hyperplastic polyps assessed by light microscopy. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study group a: After 6 months of treatment
Study group b: After 4 - 6 weeks |
|
E.5.2 | Secondary end point(s) |
Ease of administration, adverse effects. |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |