Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05476172 |
| Other study ID # |
2022-8/23 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Uludag University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This randomized controlled study aims to investigate the efficiency of medical treatment
modalities in endometriosis patients. The study protocol involves two arms. (Dienogest Group
and Noretindrone Acetate Group). The patients diagnosed with endometriosis are randomized
depending on their protocol ids. The Dienogest group is prescribed 5 mg dienogest per day and
neta group is prescribed 5 mg neta per day. The pain scores will be analyzed six months and
twelve months after treatment.
Description:
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.
4. STUDY POPULATION File analysis of all patients between the ages of 18-40 who applied to
our center with the diagnosis of endometriosis and met the inclusion criteria will be
performed.
CRITERIA FOR INCLUSION
- Patients aged between 18 and 40 who applied to our Endometriosis and Chronic Pelvic Pain
Outpatient Clinic
- Patients who do not want pregnancy
- Patients with a diagnosis of endometriosis and a medical suppression indication due to
pain.
EXCLUSION CRITERIA
- Patients who are contraindicated to use progesterone
- Patients who have developed an allergic reaction to the progesterone preparations used
and the active ingredients in it
- Patients with pelvic inflammatory disease accompanying endometriosis
- Patients diagnosed with uterine malformation with previous surgery
- Patients with obstructive genitourinary and gastrointestinal symptoms and indication for
surgical treatment
STUDY CENTER Bursa Uludağ University Faculty of Medicine Hospital, Department of Obstetrics
and Gynecology Endometriosis and Chronic Pelvic Pain Polyclinic DETERMINATION OF STUDY
POPULATION It is planned to recruit patients between the ages of 18-40 who receive medical
treatment indications in Bursa Uludağ University Medical Faculty Hospital, Department of
Gynecology and Obstetrics Endometriosis and Chronic Pelvic Pain Polyclinic.
DIAGNOSIS AND TREATMENT PROTOCOL The files of patients who applied to Bursa Uludağ University
Gynecology and Obstetrics Department Endometriosis and Chronic Pelvic Pain Polyclinic and
started medical treatment will be examined.
The progesterone treatment protocols routinely used in the Endometriosis and Chronic Pelvic
Pain Outpatient Clinic are as follows;
1. The use of progesterone, which is started on the second day of the menstrual cycle and
continued uninterruptedly (norethindrone acetate 5 mg tablet p.o. 1x1 in posology)
2. Progesterone use, which is started on the second day of the menstrual cycle and
continued uninterruptedly (dienogest 2 mg tablet p.o. 1x1 in posology). Apart from the
routine operation of the clinic, no non-routine procedures will be performed in the
study. The study supervisor does not have the authority to be involved in the treatment
and change the protocol. It will only observe and analyze data of treatment protocols
initiated from the file.
MATERIALS AND METHODS Patients who applied to the Department of Obstetrics and Gynecology
Endometriosis and Chronic Pelvic Pain Polyclinic and received medical suppression treatment
indications were included in the study.
No changes will be made in the treatment and follow-up protocols of the patients for the
purpose of the study. Patients who are started on medical treatment are routinely called for
follow-up at 6-month intervals. At the beginning of the treatment, at the 6th and 12th months
of the treatment, all patients will be routinely visited. Patients will not be included in
the evaluation of additional controls and examinations for the purpose of the study. The
current evaluations of the patients in treatment will be recorded. Patients who are on the
protocol of 2 different progesterone derivatives recommended by the guidelines and applied in
our clinic will be compared among themselves in terms of laboratory parameters,
ultrasonographic evaluations, and numerical scoring systems for chronic pain symptoms, and
the effects of these values on treatment effectiveness and recurrence outcomes will be
evaluated and the records in the patient files will be examined. The research will be carried
out by collecting data from patient files, and the study we have done will not cause any
change in the current treatment of patients.
DURATION OF STUDY The duration of the study is 12 months.
