Endometriosis Urological and Genital Diseases
Conditions
Interventions
An observational prospective study will be conducted at King Chulalongkorn Memorial Hospital. The expected duration of subject participation is approximately 6 months.
Subjects visiting gynaecology co
Sponsors
Exeltis Thailand
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female patients, age = 18 and = 45 years. 2. Present at least one classical symptom of endometriosis associated pain including dysmenorrhea, dyspareunia, chronic pelvic pain, dysdefecation without any other pathology by taking a history or physical examination plus Visual Analogue Scale (VAS) = 4 3. Decision taken by the physician to prescribe Dienogest 2 mg
Exclusion criteria
Exclusion criteria: 1. Current Body mass Index (BMI) > 30 kg/m² 2. Patients with severe acute or chronic diseases (e.g. pancreatitis, hypertriglyceridemia, liver disease, benign or malignant liver tumor, malignant sex-hormone dependent diseases of genitals or breasts) 3. Intake of herbal medicines or medicines which induce microsomal enzymes, especially cytochrome-P450-enzyme, e.g. Phenytoin, Phenobarbital, Primidon Bosentan, Carbamazepine, Rifampicin, Topiramate, Felbamat, Griseofulvin, a few HIV protease inhibitors (e.g. Ritonavir), and non-nucleosidic Reverse-Transcriptase-Inhibitors (e.g. Efavirenz) as well as preparations of Aaron´s beard. 4. History of cardiovascular events 5. Advanced hypertension or diabetes 6. Known hypersensitivity to components of Dienogest 7. Undiagnosed abnormal vaginal bleeding 8. Use of drugs containing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir during and two weeks before start of the study 9. Patients using intrauterine devices (IUD) or intrauterine systems (IUS) 10. Pregnancy 11. Breast feeding 12. Patients who are postmenopausal 13. Patients switching from a GnRH agonist, hormonal contraception, or progestin treatment within 3 months 14. Participation in any other trial 30 days before starting to use Dienogest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endometriosis-associated pain symptoms after 3 months and 6 months of Dienogest treatment measured using a questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability and safety aspects after the use of Dienogest for 6 months measured using routine controls | — |
Countries
Thailand
Contacts
Public ContactPedro Antonio Regidor
Outcome results
None listed