Clinical trial NCT03690765: Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: endometriosis
dydrogesterone
Duphaston®
progestogens
pelvic pain
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2018-10-01
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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®

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in chronic pelvic pain intensity
timeFrame: 6 months
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: 3 months, 6 months
measure: Change in chronic pelvic pain intensity
timeFrame: 3 months, 6 months
measure: Cycles' duration
timeFrame: 6 months
measure: Change in dysmenorrhea
timeFrame: 3 months, 6 months
measure: Analgesics using
timeFrame: 6 months
measure: Sexual wellbeing
timeFrame: 6 months
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical University, Department of Obstetrics and Gynecology
city: Ekaterinburg
country: Russian Federation
facility: FOTEK Medical Holding LLC, Women's Clinic
city: Engel's
country: Russian Federation
facility: Engels Perinatal Center
city: Kazan
country: Russian Federation
facility: City Hospital №11
city: Kemerovo
country: Russian Federation
facility: Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center
city: Krasnodar
country: Russian Federation
facility: Kuban State Medical University. Regional Clinical Hospital №2
city: Krasnoyarsk
country: Russian Federation
facility: Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk Regional Clinical Center for the Protection of Motherhood and Childhood
city: Krasnoyarsk
country: Russian Federation
facility: Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic
city: Moscow
country: Russian Federation
facility: RZD Central Clinical Hospital № 6
city: Moscow
country: Russian Federation
facility: Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
city: Moscow
country: Russian Federation
facility: Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
city: Novgorod
country: Russian Federation
facility: Semashko Nizhny Novgorod Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Clinical Center for Family Health and Reproduction of the Novosibirsk Region
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University, Research institute of obstetrics and pediatrics
city: Saint Petersburg
country: Russian Federation
facility: Pavlov First St. Petersburg State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Ott Research Institute of Obstetrics, Gynecology and Reproductology
city: Stavropol'
country: Russian Federation
facility: Stavropol State Medical University
city: Tyumen
country: Russian Federation
facility: State Hospital Perinatal Center
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Voronezh
country: Russian Federation
facility: Clinic "New Medical Technologies"
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Hospital №1, Voronezh Regional Perinatal Center
Study officials:
affiliation: Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology
name: Andrey V Kozachenko, Prof
role: STUDY_CHAIR
References:
citation: 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.