The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis

The aim of this observational drug study was to evaluate the patients with medical treatment indications who applied to Bursa Uludağ University Medical Faculty Hospital, Department of Obstetrics and Gynecology, Endometriosis and Chronic Pelvic Pain Outpatient Clinic, during the application of 2 different progesterone protocols with proven efficacy, which are currently recommended for routine use, with 6-month periods and three doses. To compare the effects of different progesterone-derived protocols in use and their effects on treatment effectiveness and recurrence by evaluating ultrasonographic parameters, laboratory parameters, and numerical scoring system scores of patients on chronic pain symptoms (dysmenorrhea, dyspareunia, dysgeusia, and chronic pelvic pain) at different visits.

It was designed as a one-time prospective, randomized observational study. Patients who applied to the Endometriosis and Chronic Pelvic Pain Polyclinic and were evaluated by the relevant faculty members and received medical treatment indications will be randomly assigned to one of the two treatment protocols used as single-digit 'norethindrone acetate' and double-digit 'dienogest' according to the last digit of the current hospital protocol numbers in the system. At the time of the first application, the patients will be recorded in the patient files together with their personal and demographic data, the duration of the previous treatments and the reasons for their discontinuation, the operation notes, and centers of their previous surgeries due to endometriosis, if any. Patients will be evaluated with ultrasonographic evaluations and detailed physical examinations, and laboratory tests. In the ultrasonographic evaluation, uterine contours, presence of adenomyosis, detailed evaluation of the adnexal area, if there is the presence of endometrioma, its size, and the evaluation of the Douglas cavity will be made in detail. Physical examination includes vaginal and rectal examination, and tenderness and nodular appearance will be evaluated. Laboratory parameters include complete blood count, biochemical parameters, tumor markers, and anti-mullerian hormone levels, which we routinely check in the endometriosis outpatient clinic. It will be evaluated and recorded at each visit.

Patients will be questioned for existing dyspareunia, dysmenorrhea, dysgeusia, and chronic pelvic pain. Grades will be written by asking the patients to give a score between 1-10 with the numerical scoring system for their existing pain complaints. In addition, accompanying gastrointestinal and genitourinary symptoms will be noted in the patient's file.

Patients will be reassessed at 6 and 12 months while on treatment with progestins given according to protocol numbers. In addition, at each visit, patients will be evaluated for possible side effects of medical treatment and recorded. In terms of side effects, patients will be asked to give points between 1-10 with the numerical scoring system. Any other side effects will be recorded in the patient file. The information of these records will be taken from the file by the responsible worker after each visit and recorded in the study forms. The study supervisor is not authorized to determine or change the patient's treatment protocol.

In statistical analysis, a comparison between the groups will be made with the Kruskal Wallis test as a non-parametric test using the SPSS-22 program. P value <0.05 will be considered statistically significant.