To Evaluate Efficacy And Safety of Thymosin Alpha One Plus Standard of Care (SOC) in Comparison with SOC Alone in Patients with Confirmed Endometriosis.

Phase 3

Active, not recruiting

Conditions: Health Condition 1: D899- Disorder involving the immune mechanism, unspecified

Registration Number: CTRI/2023/06/054279

Lead Sponsor: Gufic Biosciences 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 patients between the age group =18and = 49 years of age at the time of

consent

2. Patients with a confirmed diagnosis of Endometriosis (up to stage III) based on

laparoscopy or imaging

3. Patients having negative urine pregnancy test at the time of screening and agree to

the use of barrier contraception during the study period

4. Patients who are willing to comply with study procedures and restrictions

5. Patients who can and are willing to provide signed informed consent

Exclusion Criteria

1. Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial

ablation resulting in amenorrhea

2. Candidate for elective gynaecological surgery [Dilation and Curettage (D&C),

cervical cryosurgery, colposcopy, Loop Electrosurgical Extension Procedure

(LEEP)] for next 6 months

3. Patient who had a normal or C section delivery with a gap of less than 3 months

after cessation of Lactation

4. Participation in other clinical trials in last three months and during study period

5. Patients having an unstable medical condition or chronic disease (including history

of neurological [including cognitive], hepatic, renal, cardiovascular,

gastrointestinal, pulmonary, or endocrine disease), or malignancy that could

confound interpretation of the study outcomes

6. Patients having a history of positive human immunodeficiency virus antibody (HIV

Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab)

assay at Screening or have a history of a positive result

7. Pregnant and lactating female lactating at the time of screening and willing to

continue lactating during the study

8. Any other condition, which as per the investigator would jeopardize the outcome of

the trial

9. Patients who, in the judgment of the investigator, will be unlikely to comply with

the requirements of this protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the efficacy of Thymosin a 1 in <br/ ><br>combination with SOC versus SOC alone in patients with <br/ ><br>endometriosis in terms of endometriosis associated pain assessed by a <br/ ><br>Visual Analogue Scale (VAS) scoreTimepoint: Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180

Secondary Outcome Measures

Name	Time	Method
• To evaluate and compare the efficacy of Thymosin a 1 in <br/ ><br>combination with SOC versus SOC alone in patients with <br/ ><br>endometriosis in terms of Dysmenorrhea (DYS) pain scale score, <br/ ><br>Dyspareunia (DYSP) pain scale score, Non-Menstrual Pelvic Pain <br/ ><br>(NMPP) pain scale, lower back pain, dyschezia related pain on NRS, <br/ ><br>and overall size of Endometriosis. <br/ ><br>• To assess and compare the safety of Thymosin a 1 in combination <br/ ><br>with SOC versus SOC alone.Timepoint: Day 1, Day 30, Day 60, Day 90, Day 135 and Day 180