To assess how safe and effective Visanne (Dienogest) is in managing pelvic pain caused due to endometriosis

Phase 4

Active, not recruiting

Conditions: Endometriosis, unspecified,

Registration Number: CTRI/2022/04/041870

Lead Sponsor: Bayer Pharmaceuticals Pvt Ltd

Brief Summary: Endometriosis is a chronic, progressive, estrogen-dependent disease of unknown aetiology, with a prevalence rate of up to 10% in women in reproductive age-group. Since there is no known cure for endometriosis, management is aimed at reducing pain, minimizing disease progression and preserving fertility. Dienogest is a progestin with both local and central effects in reducing endometriosis associated pelvic pain, with a good

safety profile. Based on the information from the clinical developmental program for Dienogest the Indian Health Authority (DCGI) has approved Dienogest for the management of pelvic pain associated with endometriosis and requested to carry out a phase IV post-approval study. The proposed regulatory postapproval Phase IV study is planned to assess the safety and effectiveness of Dienogest in patients in India with endometriosis associated pelvic pain, in real world clinical practice.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Female

Target Recruitment: 160

Inclusion Criteria

Female patients in India at least 18 years of age Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst) Patients diagnosed with endometriosis associated pelvic pain who have not been previously treated with Dienogest Decision to initiate treatment with Dienogest was made as per investigatorâ€™s routine treatment practice Signed informed consent.

Exclusion Criteria

Participation in an investigational program with interventions outside of routine clinical practice Contra-indications according to the local summary of product characteristics (SPC).

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective in this study is:	0 months, 3 months and 6 months
to assess the incidence of adverse events, in Indian Endometriosis patients on Dienogest therapy.	0 months, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Change in endometriosis associated pelvic pain from baseline at six months, measured by 0-10	EAPP NRS.

Trial Locations

Locations (14): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
Amins Hospital for Women
🇮🇳
Ahmadabad, GUJARAT, India
Apollo Gleneagles Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Apollo Hospitals
🇮🇳
Khordha, ORISSA, India
Calcutta National Medical College
🇮🇳
Kolkata, WEST BENGAL, India
Fortis Hospital
🇮🇳
Bangalore, KARNATAKA, India
Healthworld Hospitals
🇮🇳
Barddhaman, WEST BENGAL, India
Institute of Medical Sciences, Banaras Hindu University
🇮🇳
Varanasi, UTTAR PRADESH, India
Max Smart Super Speciality Hospital
🇮🇳
Delhi, DELHI, India
Paras Hospital
🇮🇳
Gurgaon, HARYANA, India
Scroll for more (4 remaining)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Vidushi Kulshreshtha
Principal investigator
9891910880
drvidushi.kul@gmail.com