A study to evaluate the safety and efficacy of Dienogest in patients suffering from endometriosis

Phase 4

Active, not recruiting

• Conditions: Endometriosis, unspecified,

• Registration Number: CTRI/2020/10/028556
• Lead Sponsor: Jagsonpal Pharmaceuticals Limited

Brief Summary

This is a, multicentre, prospective, open labeled phase IV study to evaluate safety and efficacy of Dienogest 2mg daily for 12 weeks (90 days) in patients suffering from endometriosis that will be conducted across various sites in India. The primary safety variables include:

1.Adverse events (based on severity grades, patterns, and causality)

2. Serious adverse events (SAE; in terms of severity)

3. Clinically significant derangement in laboratory parameters

4. Clinically significant changes in vital signs, demographics, gynaecologic examination, breast examination, bleeding pattern (number of days, number of episodes, and duration of episodes with bleeding/spotting or spotting only)

Other safety variable are

Tolerability: The assessment of tolerability will be performed by the investigator based on investigator assessment questionnaire. The responses will be graded as “excellentâ€, “goodâ€, “fairâ€, and “not well toleratedâ€.

Efficacy

Primary variables

Clinical response: Clinical responses will be evaluated on the basis of changes in clinical sign/symptoms, lesion reduction and reduction in pain intensity in terms of dysmenorrhea and low back pain in endometriosis and are categorized as “cure†and “failureâ€. These are defined as follows:

1.Cure: Resolution of clinical signs and symptoms of original disease, not requiring further treatment

2. Failure: Persistence of clinical signs and symptoms or worsening in signs and symptoms that required alternative treatment or death. To categorize as clinical failure at least three weeks of therapy should have been administered

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-29
• Last Update Posted: 2023-09-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients with a confirmed diagnosis of Endometriosis based on laparoscopy or imaging 2.Patients who receive a prescription of DIENOGEST according to the indication stated in the local approved SmPC.
• 3.Written informed consent signed by the patient or legally acceptable representative(s) in line with applicable re.gulation of country.
• 4.Planned treatment in line with the Summary of Product Characteristics, i.e. exclusion of all patients with contraindications.

Exclusion Criteria

1.Exclusion of all patients with contraindications as per Investigators discretion.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety	After end of treatment ie., 12 weeks (90 days)
of adverse events and change in laboratory tests.	After end of treatment ie., 12 weeks (90 days)
The criteria for the assessment of safety and tolerability will be described in terms	After end of treatment ie., 12 weeks (90 days)
1.Adverse events (based on severity grades, patterns, and causality).	After end of treatment ie., 12 weeks (90 days)
2.Serious adverse events (SAE; in terms of severity)	After end of treatment ie., 12 weeks (90 days)
3.Clinically significant derangement in lab results	After end of treatment ie., 12 weeks (90 days)
4.Clinically significant changes in vital signs, demographics, gynaecologic	After end of treatment ie., 12 weeks (90 days)
examination, breast examination, bleeding pattern.	After end of treatment ie., 12 weeks (90 days)

Secondary Outcome Measures

Name	Time	Method
Efficacy	Clinical response: Clinical responses will be evaluated on the basis of changes in

Trial Locations

Locations (6)

AIIMS Bhubneshwar; 🇮🇳 Khordha, ORISSA, India

JawaharLal Nehru Medical College and Attached Hospital; 🇮🇳 Ajmer, RAJASTHAN, India

Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University; 🇮🇳 Aligarh, UTTAR PRADESH, India

Kasturba Medical College, MAHE-Manipal; 🇮🇳 Udupi, KARNATAKA, India

Sher-i-Kashmir Institute of Medical Sciences (SKIMS); 🇮🇳 JAMMU, & KASHMIR, India

Shubham Sudbhawana Superspeciality Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

AIIMS Bhubneshwar

🇮🇳Khordha, ORISSA, India

Dr Pruthwiraj Sethi

Principal investigator

9438884132

drpruthwiraj@gmail.com