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

NCT03690765 | Completed

• 1 other identifier: DYDR5004
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 21

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

Conditions

Endometriosis

Keywords

endometriosis; dydrogesterone; Duphaston®; progestogens; pelvic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Quality of Life

  3 months, 6 months

• Change in chronic pelvic pain intensity

  3 months, 6 months

• Cycles' duration

  6 months

• Change in dysmenorrhea

  3 months, 6 months

• Analgesics using

  6 months

Study Arms (1)

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)

Interventions

Duphaston® (Dydrogesterone) 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.

Endometriosis/Dydrogesterone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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®

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (21)

South Ural State Medical University, Department of Obstetrics and Gynecology

Chelyabinsk, 454076, Russia

Location

Engels Perinatal Center

Engel's, 413116, Russia

Location

City Hospital №11

Kazan', 420127, Russia

Location

Kemerovo State Medical University, Reshetov Kemerovo Regional Perinatal Center

Kemerovo, 650066, Russia

Location

Kuban State Medical University. Regional Clinical Hospital №2

Krasnodar, 350012, Russia

Location

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

Krasnoyarsk, 660022, Russia

Location

Voyno-Yasenetsky Krasnoyarsk State Medical University, Professorial clinic

Krasnoyarsk, 660049, Russia

Location

RZD Central Clinical Hospital № 6

Moscow, 109388, Russia

Location

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, 117997, Russia

Location

Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

Moscow, Russia

Location

Clinical Center for Family Health and Reproduction of the Novosibirsk Region

Novosibirsk, 630136, Russia

Location

Rostov State Medical University, Research institute of obstetrics and pediatrics

Rostov-on-Don, 344022, Russia

Location

Pavlov First St. Petersburg State Medical University

Saint Petersburg, 197022, Russia

Location

Ott Research Institute of Obstetrics, Gynecology and Reproductology

Saint Petersburg, 199034, Russia

Location

Stavropol State Medical University

Stavropol, 355017, Russia

Location

State Hospital Perinatal Center

Tyumen, 625002, Russia

Location

Bashkir State Medical University

Ufa, 450092, Russia

Location

Semashko Nizhny Novgorod Regional Clinical Hospital

Veliky Novgorod, 603126, Russia

Location

Clinic "New Medical Technologies"

Voronezh, 394024, Russia

Location

Voronezh Regional Clinical Hospital №1, Voronezh Regional Perinatal Center

Voronezh, 394066, Russia

Location

FOTEK Medical Holding LLC, Women's Clinic

Yekaterinburg, 620137, Russia

Location

Related Publications (1)

• 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.

  PMID: 34465452 DERIVED

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Andrey V Kozachenko, Prof

  Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 1, 2018
• Study Start: September 27, 2018
• Primary Completion: November 10, 2019
• Study Completion: May 29, 2020
• Last Updated: December 28, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (21)