Real world study of Dydrogesterone in endometriosis

Phase 4

Conditions: Health Condition 1: N809- Endometriosis, unspecified

Registration Number: CTRI/2022/11/047677

Lead Sponsor: Zydus Healthcare Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Female, aged = 18 years and = 45 years.

2. Complaints on chronic pelvic pain with or without dysmenorrhea assessed by 11-items NRS.

3. External genital endometriosis confirmed by clinical evaluation, or imaging analysis (ultrasonography) of endometriotic ovarian chocolate cysts.

4. Eligible to be prescribed treatment with dydrogesterone according to labeling for treatment of endometriosis.

5. No hormonal treatment in 2 cycles before enrolment.

6. Willing to provide written informed consent

Exclusion Criteria

1. Routine consumption of analgesics other than for the pain of endometriosis.

2. Patients receiving hormonal contraceptives in the last 2 cycles (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives, etc.).

3. Ongoing pregnancy.

4. Contraindications to dydrogesterone listed in the locally approved label

5. Any other condition that precludes the use of dydrogesterone in accordance with the precautions and special warnings listed in the locally approved label

6. Other conditions that made the patient’s participation impossible (based on the investigator’s decision).

7. Fertility treatments using assisted reproductive technology

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in chronic pelvic pain intensity. <br/ ><br>The changes in chronic pelvic pain intensity assessed by 11-items Numerous Rating Scale (NRS) at the end of observation (Visit 3; 6-month follow-up) versus Baseline (Visit 1). 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 will be asked to point the average pain intensity throughout the last month.Timepoint: Time Frame: 6 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Change in chronic pelvic pain intensity on 11 item NRS <br/ ><br>Menstrual Period Check <br/ ><br>Change in dysmenorrhea ON 11 item NRS <br/ ><br>Analgesic used number of days each cycle <br/ ><br>Sexual well being on 5 point Likert ScaleTimepoint: Change in chronic pelvic pain (3 months) <br/ ><br>Menstrual period check (6 months) <br/ ><br>Change in dysmenorrhea (3 & 6 months) <br/ ><br>Analgesic use (3 & 6 month) <br/ ><br>Sexual well-being (6 month)