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

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)

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

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Duphaston® (Dydrogesterone); Drug: Duphaston® (Dydrogesterone)

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.

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454076
    • South Ural State Medical University, Department of Obstetrics and Gynecology
  • Ekaterinburg, Russian Federation, 620137
    • FOTEK Medical Holding LLC, Women's Clinic
  • Engel's, Russian Federation, 413116
    • Engels Perinatal Center
  • Kazan, Russian Federation, 420127
    • City Hospital №11
  • Kemerovo, Russian Federation, 650066
    • Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center
  • Krasnodar, Russian Federation, 350012
    • Kuban State Medical University. Regional Clinical Hospital №2
  • Krasnoyarsk, Russian Federation, 660022
    • Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk Regional Clinical Center for the Protection of Motherhood and Childhood
  • Krasnoyarsk, Russian Federation, 660049
    • Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic
  • Moscow, Russian Federation, 109388
    • RZD Central Clinical Hospital № 6
  • Moscow, Russian Federation, 117997
    • Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
  • Moscow, Russian Federation
    • Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
  • Novgorod, Russian Federation, 603126
    • Semashko Nizhny Novgorod Regional Clinical Hospital
  • Novosibirsk, Russian Federation, 630136
    • Clinical Center for Family Health and Reproduction of the Novosibirsk Region
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University, Research institute of obstetrics and pediatrics
  • Saint Petersburg, Russian Federation, 197022
    • Pavlov First St. Petersburg State Medical University
  • Saint Petersburg, Russian Federation, 199034
    • Ott Research Institute of Obstetrics, Gynecology and Reproductology
  • Stavropol', Russian Federation, 355017
    • Stavropol State Medical University
  • Tyumen, Russian Federation, 625002
    • State Hospital Perinatal Center
  • Ufa, Russian Federation, 450092
    • Bashkir State Medical University
  • Voronezh, Russian Federation, 394024
    • Clinic "New Medical Technologies"
  • Voronezh, Russian Federation, 394066
    • Voronezh Regional Clinical Hospital №1, Voronezh Regional Perinatal Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Females aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston®

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Endometriosis/Dydrogesterone; Females aged 18 to 45 years, suffering external genital endometriosis confirmed by laparoscopy, for whom were prescribed treatment with Duphaston®

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.; Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Chair: Andrey V Kozachenko, Prof, Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Publications and helpful links

General Publications

• Sukhikh GT, Adamyan LV, Dubrovina SO, Baranov II, Bezhenar VF, Kozachenko AV, Radzinsky VE, Orazov MR, Yarmolinskaya MI, Olofsson JI. Prolonged cyclical and continuous regimens of dydrogesterone are effective for reducing chronic pelvic pain in women with endometriosis: results of the ORCHIDEA study. Fertil Steril. 2021 Dec;116(6):1568-1577. doi: 10.1016/j.fertnstert.2021.07.1194. Epub 2021 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): November 10, 2019
• Study Completion (Actual): May 29, 2020

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: endometriosis; pelvic pain; dydrogesterone; Duphaston®; progestogens
• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Dydrogesterone
• Other Study ID Numbers: DYDR5004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No