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

Endometriosis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690765
• Other study ID #: DYDR5004
• Status: Completed
• Start date: September 27, 2018
• Est. completion date: May 29, 2020

Study information

• Verified date: June 2019
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 29, 2020
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Duphaston® (Dydrogesterone)
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.
• Duphaston® (Dydrogesterone)
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.

Locations

Country	Name	City	State
Russian Federation	South Ural State Medical University, Department of Obstetrics and Gynecology	Chelyabinsk
Russian Federation	FOTEK Medical Holding LLC, Women's Clinic	Ekaterinburg
Russian Federation	Engels Perinatal Center	Engel's
Russian Federation	City Hospital ?11	Kazan
Russian Federation	Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center	Kemerovo
Russian Federation	Kuban State Medical University. Regional Clinical Hospital ?2	Krasnodar
Russian Federation	Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk Regional Clinical Center for the Protection of Motherhood and Childhood	Krasnoyarsk
Russian Federation	Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic	Krasnoyarsk
Russian Federation	Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology	Moscow
Russian Federation	Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology	Moscow
Russian Federation	RZD Central Clinical Hospital ? 6	Moscow
Russian Federation	Semashko Nizhny Novgorod Regional Clinical Hospital	Novgorod
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	Ott Research Institute of Obstetrics, Gynecology and Reproductology	Saint Petersburg
Russian Federation	Pavlov First St. Petersburg State Medical University	Saint Petersburg
Russian Federation	Stavropol State Medical University	Stavropol'
Russian Federation	State Hospital Perinatal Center	Tyumen
Russian Federation	Bashkir State Medical University	Ufa
Russian Federation	Clinic "New Medical Technologies"	Voronezh
Russian Federation	Voronezh Regional Clinical Hospital ?1, Voronezh Regional Perinatal Center	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cycles' duration	Description of the cycles' duration during 6-months treatment by Duphaston® in patients with endometriosis	6 months
Secondary	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
Secondary	Analgesics using	A number of days per each cycle (1-6) when analgesics were self-administered	6 months
Secondary	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