A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions in Indian Women With Endometriosis

NCT04808843 | Completed

• 1 other identifier: 19837
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that normally covers the inside of the womb grows outside the womb. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life. It also requires long-term treatment to control the symptoms. The study drug, dienogest, has already been approved as a treatment for endometriosis associated pelvic pain. Sometimes, researchers continue studying a treatment after it has been approved to learn more about its safety. In this study, the researchers want to learn more about any medical problems the patients have while taking dienogest. To answer this question, the researchers will collect the medical problems the patients have after taking dienogest and that may or may not be related to dienogest. These medical problems are also known as adverse events. They will also collect information about the endometriosis associated pelvic pain. The pain measured with a standard rating scale called EAPP (endometriosis-associated pelvic pain) before treatment start and after 6 months of treatment will be compared. The trial will include women with endometriosis associated pelvic pain whose doctors have decided to start treating them with dienogest. It will include about 160 women in India who are at least 18 years old. All of the patients will take dienogest based on their doctor's instructions. They will then visit their study site 3 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. The doctors will do tests to measure the pain caused by the patients' endometriosis and any other symptoms. The doctors will also do physical examinations and check the patients' overall health.

Conditions

Endometriosis Associated Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events that occur during treatment with Dienogest

  Will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system

  6 months

Secondary Outcomes (1)

• Change in endometriosis associated pelvic pain

  6 months

Study Arms (1)

Dienogest

Patients with endometriosis who have been prescribed with Dienogest.

Drug: Dienogest (BAY86-5258, Visanne)

Interventions

Dienogest (BAY86-5258, Visanne) DRUG

Following the physicians' decision.

Dienogest

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Indian female patients diagnosed with endometriosis.

You may qualify if:

• 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 investigator's routine treatment practice
• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, India

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Interventions

dienogest

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: May 13, 2022
• Primary Completion: February 5, 2024
• Study Completion: September 23, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)