check_circleStudy Completed
Endometriosis associated pelvic pain
Bayer Identifier:
19837
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
A study to learn more about how safe dienogest is and how well it works under real world conditions in Indian women with endometriosis
Trial purpose
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.
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.
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
160Trial Dates
May 2022 - September 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Visanne (Dienogest, BAY86-5258)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, India |
Primary Outcome
- Number of participants with adverse events that occur during treatment with DienogestWill be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding systemdate_rangeTime Frame:6 months
Secondary Outcome
- Change in endometriosis associated pelvic painMeasured by Numerical Rating Scale (NRS) on an 0-10 EAPP (Endometriosis Associated Pelvic Pain) NRS with “absence of pain” corresponding to the value “0” and “unbearable pain” corresponding to the value “10”.date_rangeTime Frame:6 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A