Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
- Registration Number
- NCT03690765
- Lead Sponsor
- Abbott
- Brief Summary
A non-interventional, observational program to assess the effects of dydrogesterone (Duphaston®) 6-months-administration in patients with confirmed endometriosis in a post-marketing setting in the Russian Federation
- Detailed Description
A non-interventional, observational program to assess the effects of oral dydrogesterone therapy in a post-marketing setting whether the effects are related to the regimen of dydrogesterone therapy. In this observational program, assuming that dydrogesterone plays a role in the treatment of endometriosis without suppression of ovulation, the goal is to observe the possible implications of such treatment in terms of treatment regimen and response pattern. In the study will be described effects of Duphaston® 6-months-administration in patients with confirmed endometriosis by assessing pain relief, quality of life, need of self-medication with analgesics, etc.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 350
- Female, aged ≥ 18 years and ≤ 45 years.
- Complaints on chronic pelvic pain with or without dysmenorrhea assessed by 11-items NRS.
- External genital endometriosis confirmed by laparoscopy.
- Existing pelvic (vaginal) ultrasound data not earlier than 2 months before inclusion in the study.
- Prescribed treatment with Duphaston® according local labelling for treatment of endometriosis 10 mg 2-3 times a day from the 5th to the 25th day of the menstrual period cycle or continuously.
- No hormonal treatment in 2 cycles before enrollment.
- Signed Patient Authorization for Use/Disclosure of Data.
- Any co-existing disease(s) needing chronic drug therapy (e.g. Crohn's disease, diabetes etc); Severe concomitant medical illness.
- Severe other genital pathology excluding endometriosis (e.g. Multiple/severe myoma; adenomyosis, inflammatory diseases, etc.).
- Routine consumption of analgesics other than for the pain of endometriosis.
- Patients receiving hormonal contraceptives in last 2 cycles (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives etc.).
- Ongoing pregnancy.
- Menopause or premature ovarian failure.
- Contraindications to dydrogesterone treatment listed in the locally approved label (Instructions for the medical use of Duphaston®).
- Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions and special warnings listed in the locally approved label (Instructions for the medical use of Duphaston®).
- Abnormal results of pap smear test.
- Other conditions that made the patients participation impossible (based on the investigator decision).
- Fertility treatments using assisted reproductive technology.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endometriosis/Dydrogesterone Duphaston® (Dydrogesterone) Females aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston®
- Primary Outcome Measures
Name Time Method Change in chronic pelvic pain intensity 6 months The changes in chronic pelvic pain intensity assessed by 11-items Numerous Rating Scale (NRS) at the end of observation (Visit 3) versus Baseline (Visit 1) in the prolonged cyclic regime and the continuous regime of Duphaston in patients with endometriosis. The 11-items Numerous Rating Scale (NRS) contains the range from 0 to 10, where 0 represents 'no pain' and 10 represents 'the worst pain'. Patients are asked to point the average pain intensity throughout the last month. The negative change corresponds to better result.
- Secondary Outcome Measures
Name Time Method Sexual wellbeing 6 months Description of the change in sexual wellbeing assessed by A Quality Assessment of Patient-Reported Outcome Measures for Sexual Wellbeing (5-points Likert scale) at the end of observation (Visit3) versus Baseline (Visit1). A Quality Assessment of Patient-Reported Outcome Measures for Sexual Wellbeing by 5-points Likert scale proposes patients to rate themselves on a 5-point scale as being 'very satisfied, satisfied, ordinarily, rather not satisfied, not satisfied'. The number (and proportion) of patients in each category will be presented.
Cycles' duration 6 months Description of the cycles' duration during 6-months treatment by Duphaston® in patients with endometriosis
Analgesics using 6 months A number of days per each cycle (1-6) when analgesics were self-administered
Change in chronic pelvic pain intensity 3 months, 6 months Change in Patient-reported severity of chronic pelvic pain assessed by 11-items NRS after 3-months treatment (Visit2) and after 6-months treatment (Visit3) versus Baseline (Visit1) in patients with endometriosis
Change in Quality of Life 3 months, 6 months Changes in Quality of Life assessed by Short Form-20 (SF-20) at the end of observation (Visit3) versus Baseline (Visit1) in patients with endometriosis. The Short Form-20 (Copyright © the RAND Corporation) consists of 20 questions grouped into two parameters: psychological and physical components of health. The indicators of each scale are compiled in such a way that the higher the value of the indicator (from 0 to 100), the better the score on the chosen parameter.
Change in dysmenorrhea 3 months, 6 months Description of the changes in dysmenorrhea assessed by 11-items NRS after 3-months treatment (Visit2) and after 6-months treatment (Visit3) versus Baseline (Visit1) in patients with endometriosis. The 11-items Numerous Rating Scale (NRS) contains the range from 0 to 10, where 0 represents 'No symptoms' and 10 represents 'the Worst trouble'. Patients are asked to point the average intensity of dysmenorrhea symptoms (cyclic pelvic pain, mood disorders, gastro-intestinal symptoms etc.) during the last menses period. The negative change corresponds to better result.
Trial Locations
- Locations (20)
FOTEK Medical Holding LLC, Women's Clinic
🇷🇺Ekaterinburg, Russian Federation
Bashkir State Medical University
🇷🇺Ufa, Russian Federation
South Ural State Medical University, Department of Obstetrics and Gynecology
🇷🇺Chelyabinsk, Russian Federation
Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center
🇷🇺Kemerovo, Russian Federation
RZD Central Clinical Hospital № 6
🇷🇺Moscow, Russian Federation
Clinical Center for Family Health and Reproduction of the Novosibirsk Region
🇷🇺Novosibirsk, Russian Federation
Rostov State Medical University, Research institute of obstetrics and pediatrics
🇷🇺Rostov-on-Don, Russian Federation
Clinic "New Medical Technologies"
🇷🇺Voronezh, Russian Federation
Engels Perinatal Center
🇷🇺Engel's, Russian Federation
City Hospital №11
🇷🇺Kazan, Russian Federation
Semashko Nizhny Novgorod Regional Clinical Hospital
🇷🇺Novgorod, Russian Federation
Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk Regional Clinical Center for the Protection of Motherhood and Childhood
🇷🇺Krasnoyarsk, Russian Federation
Kuban State Medical University. Regional Clinical Hospital №2
🇷🇺Krasnodar, Russian Federation
Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic
🇷🇺Krasnoyarsk, Russian Federation
Pavlov First St. Petersburg State Medical University
🇷🇺Saint Petersburg, Russian Federation
Ott Research Institute of Obstetrics, Gynecology and Reproductology
🇷🇺Saint Petersburg, Russian Federation
State Hospital Perinatal Center
🇷🇺Tyumen, Russian Federation
Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
🇷🇺Moscow, Russian Federation
Stavropol State Medical University
🇷🇺Stavropol', Russian Federation
Voronezh Regional Clinical Hospital №1, Voronezh Regional Perinatal Center
🇷🇺Voronezh, Russian Federation