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

Abbott

Status: Completed

Conditions: Endometriosis

Treatments: Drug: Duphaston® (Dydrogesterone)

Study type: Observational

Funder types: Industry

Identifiers

NCT03690765

DYDR5004

Details and patient eligibility

About

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

Full 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.

Enrollment: 350 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 1 patient group

Endometriosis/Dydrogesterone

Description:

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

Treatment:

Drug: Duphaston® (Dydrogesterone)

Drug: Duphaston® (Dydrogesterone)