Endometriosis
Conditions
Interventions
Non Interventional Study. Participants will receive dydrogesterone as per routine clinical practice.
No control group. All participants will receive dydrogesterone as per routine clinical practice.
Sponsors
Abbott Healthcare Products B.V.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients =18 and =45years of age at the time of recruitment. 2. Any complaints of chronic pelvic pain with or without dysmenorrhea assessed by an 11-item numeric rating scale (NRS). 3.A diagnosis of pelvic endometriosis, confirmed by imaging [ultrasound and/or Magnetic Resonance Imaging (MRI)], and/or laparoscopy, and/or strong clinical data. 4.Prescribed treatment with dydrogesterone (Duphaston®) according to the local labeling for treatment of endometriosis (10 mg2-3 times a day from the 5th to the25th day of the menstrual period cycle or continuously). 5. Patients agree to sign informed consent for study participation, use, and disclosure of data.
Exclusion criteria
Exclusion criteria: 1. Any concomitant severe systemic disease or genital disorder. 2. Any concomitant or previous conditions requiring continuous medical treatment (e.g., adenomyosis, multiple myoma, or other related inflammatory diseases) 3. Regular use of analgesics not intended to relieve endometriosis-related chronic pelvic pain. 4. Patients receiving hormonal contraceptives during the previous two menstrual cycles (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives, Gonadotropin-Releasing Hormone agonist “GnRHa”, etc.). 5. Participants with ongoing pregnancy. 6. Menopause or premature ovarian insufficiency/failure. 7. Patients with known hypersensitivity to Duphaston® active substance or to any of the excipients. 8. Patients with known or suspected progestogen-dependent neoplasms(e.g., meningioma) 9. Patients with undiagnosed vaginal bleeding 10.Any other clinical condition that precludes the 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®). 11. Abnormal results of pap smear test(cervical cytology test). 12. Any condition that makes the patient’s participation impossible (based on the investigator’s decision). 13.Treatment for infertility by assisted reproductive technology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of dydrogesterone, in reducing chronic pelvic pain from baseline to month12, based on dosage and regimen in treating women with endometriosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of dydrogesterone from baseline to month 12, based on dosage and regimen, in treating women with endometriosis in terms of: a. QoL (Quality of Life) based on Short Form Survey (SF-36). b. Menstrual cycle duration. c. Severity of dysmenorrhea d. Severity of other types of endometriosis-induced pain. e. Need for pain self-medication with analgesics. f. Changes in sexual wellbeing. 2. To determine the occurrence of pregnancy, from baseline to month 12, based on dosage and regimen, with women with endometriosis and treated with dydrogesterone. | — |
Countries
Algeria, Egypt, Pakistan, Saudi Arabia, South Africa, Turkey, United Arab Emirates
Contacts
Public ContactCatherine Lund
CRO personnel
Outcome results
None listed