Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Open-Label Multicenter Study of Real Clinical Practice to Evaluate the Effects of Hormonal Therapy With Oral Dydrogesterone for Treatment of Confirmed Endometriosis (ORCHIDEA)

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Duphaston® (Dydrogesterone)
* Drug: Duphaston® (Dydrogesterone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endometriosis/Dydrogesterone<br>Females aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston® | Drug: Duphaston® (Dydrogesterone)<br>* No intervention. Duphaston® is prescribed 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. Description of routine practice only.<br>Drug: Duphaston® (Dydrogesterone)<br>* No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day continuously. Description of routine practice only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in chronic pelvic pain intensity | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | 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. | 3 months, 6 months | 
| Change in chronic pelvic pain intensity | 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 | 3 months, 6 months | 
| Cycles' duration | Description of the cycles' duration during 6-months treatment by Duphaston® in patients with endometriosis | 6 months | 
| Change in dysmenorrhea | 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. | 3 months, 6 months | 
| Analgesics using | A number of days per each cycle (1-6) when analgesics were self-administered | 6 months | 
| Sexual wellbeing | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, dydrogesterone, Duphaston®, progestogens, pelvic pain