Endometrial Hyperplasia Without Atypia
Conditions
Brief summary
The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.
Detailed description
Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. In this study, we aimed to compare this local treatment with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia.
Interventions
Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months.
DEVICELevonorgestrel-Intrauterine System
Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Premenopausal Patients * Patients with histologically confirmed endometrial hyperplasia without atypia
Exclusion criteria
* Endometrial hyperplasia with atypia * Endometrial Carcinoma * Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression and remission rate of endometrial hyperplasia | 3 month | Endometrial sampling will be performed for 3'th month with Carmen canula. Pathological specimens will be reported by the specialist pathologist in accordance with the World Health Organisation (WHO) endometrial hyperplasia classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Reduction From Baseline in Menstrual Blood Loss | 6 month | Menorrhagia Impact Questionnaire (MIQ). This is a validated disease-specific patient-reported outcome questionnaire assessing menstrual blood loss and the influence of heavy menstrual bleeding on quality of life |
| Number of Participants with adverse events associated with medication and device | 6 month | Any side effects will be recorded into questionnaire during a consultation with the patient |
Countries
Turkey (Türkiye)
Outcome results
None listed