Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated...
EndometriosisThe primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.
Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over...
EndometriosisThe purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: Study duration: 155 up to 285 days Treatment duration: 84 days Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic...
EndometriosisPolycystic Ovary Syndrome1 moreThe study was designed as a multicenter, prospective cross-sectional cohort study. The research population will consist of patients under the age of 40, diagnosed with endometriosis and/or adenomyosis and polycystic ovary syndrome, who applied to the obstetrics and gynecology outpatient clinics in 13 centers. According to the results of the sample size analysis, it was planned to terminate the study when 1225 patients with polycystic ovary syndrome and 1225 patients with endometriosis and/or adenomyosis were recruited.
Assess Safety and Efficacy of Vilaprisan in Subjects With Endometriosis
EndometriosisThe primary objective of this study was to assess the efficacy and safety of two doses of vilaprisan compared to placebo in women with symptomatic endometriosis. The secondary objective of this study was to evaluate the safety and tolerability of two different doses of vilaprisan in women with symptomatic endometriosis. With the implementation of protocol version 4.0 dated 11-Dec-2018, no new subjects were enrolled. The objectives above cannot be reached as only limited data is available from subjects recruited before the temporary pause.
The French E3N Prospective Cohort Study
Breast CancerColo-rectal Cancer12 moreThe French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women. The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years. Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%. A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women. Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.
Return to Work in Patients With Chronic Pain
Chronic PainEndometriosisThis study aims to evaluate whether a vocational behaviour change ability programme has any additional effect on return to work compared with return to work coordination only in persons with chronic pain.
A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated...
EndometriosisThe primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions...
Endometriosis Associated Pelvic PainEndometriosis 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.
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis...
EndometriosisPatients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological...
Ovarian CystsEndometriosis1 moreThe objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.