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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 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2025-01-22

No results posted yet for this study

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

Interventions

DRUG

Dienogest (BAY86-5258, Visanne)

Following the physicians' decision.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2024-02-05
Completion
2024-09-23

Countries

  • India

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808843 on ClinicalTrials.gov