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

NCT ID: NCT03690765

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2020-05-29

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.

Conditions

Endometriosis

Keywords

endometriosis; dydrogesterone; Duphaston®; progestogens; pelvic pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endometriosis/Dydrogesterone

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

Duphaston® (Dydrogesterone)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey V Kozachenko, Prof

Role: STUDY_CHAIR

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Locations

South Ural State Medical University, Department of Obstetrics and Gynecology

Chelyabinsk, , Russia

Engels Perinatal Center

Engel's, , Russia

City Hospital №11

Kazan', , Russia

Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center

Kemerovo, , Russia

Kuban State Medical University. Regional Clinical Hospital №2

Krasnodar, , Russia

Voyno-Yasenetsky Krasnoyarsk State Medical University, Krasnoyarsk Regional Clinical Center for the Protection of Motherhood and Childhood

Krasnoyarsk, , Russia

Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic

Krasnoyarsk, , Russia

RZD Central Clinical Hospital № 6

Moscow, , Russia

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, , Russia

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, , Russia

Clinical Center for Family Health and Reproduction of the Novosibirsk Region

Novosibirsk, , Russia

Rostov State Medical University, Research institute of obstetrics and pediatrics

Rostov-on-Don, , Russia

Pavlov First St. Petersburg State Medical University

Saint Petersburg, , Russia

Ott Research Institute of Obstetrics, Gynecology and Reproductology

Saint Petersburg, , Russia

Stavropol State Medical University

Stavropol, , Russia

State Hospital Perinatal Center

Tyumen, , Russia

Bashkir State Medical University

Ufa, , Russia

Semashko Nizhny Novgorod Regional Clinical Hospital

Veliky Novgorod, , Russia

Clinic "New Medical Technologies"

Voronezh, , Russia

Voronezh Regional Clinical Hospital №1, Voronezh Regional Perinatal Center

Voronezh, , Russia

FOTEK Medical Holding LLC, Women's Clinic

Yekaterinburg, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 34465452 (View on PubMed)

Other Identifiers

DYDR5004

Identifier Type: -

Identifier Source: org_study_id