Acceptability and satisfaction of Dienogest in the treatment of patients with symptomatic endometriosis
| ISRCTN | ISRCTN68041248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68041248 |
- Submission date
- 07/03/2024
- Registration date
- 13/03/2024
- Last edited
- 11/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
To establish the efficacy of 2 mg dienogest per day over 6 months in an Asian population for the management of endometriosis.
Who can participate?
Any patients 18 years up to 45 years with endometriosis
What does the study involve?
A hormonal treatment with 2 mg Dienogest for patients with endometriosis; this over a time of 6 months. A clinical evaluation and the recording of side effects will be performed at the months 3 and 6 of the treatment.
What are the possible benefits and risks of participating?
Benefits: A significant improvement in the endometriosis associated pain. Side effects: possible clinical signs of hypoestrogenimn like hot flushes.
Where is the study run from?
Exeltis Thailand
When is the study starting and how long is it expected to run for?
September 2023 to October 2025
Who is funding the study?
Exeltis Thailand
Who is the main contact?
Asst. Prof. Ammarin Suwan
Contact information
Public, Scientific, Principal Investigator
Adalperostr. 84
Ismaning
85737
Germany
 ORCID ID |
0000-0002-9551-2847 |
|---|---|
| Phone | +49 1738938132 |
| pedro-antonio.regidor@exeltis.com |
Study information
| Study design | Observational prospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Acceptability and satisfaction of Dienogest in the treatment of patients with symptomatic endometriosis |
| Study acronym | Endogest |
| Study objectives | To investigate acceptability and satisfaction of Dienogest in the treatment of patients with symptomatic endometriosis |
| Ethics approval(s) |
Approved 28/09/2023, Institutional Review Board, Faculty of Medicine, Chulalongkorn University (1873 Rama 4 Road 10330 Bangkok Thailand, Bangkok, 10330, Thailand; +662 256-4493; medchulairb@chula.ac.th), ref: COA No. 1267/2023 |
| Health condition(s) or problem(s) studied | Endometriosis |
| Intervention | 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 complaining about pelvic pain that the investigator suspect related to endometriosis will be identified. Thereafter, the investigator or assignee will provide information about the trial. If the patient agrees to participate, informed consent will be written. Screening procedures and baseline assessment will then take place. Treatment of endometriosis with Dienogest 2mg per day Subjects will be followed up at the 3rd and 6th month after taking dienogest for endometriosis treatment at Gynecology Outpatient Clinic, King Chulalongkorn Memorial Hospital |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Dienogest |
| Primary outcome measure | Endometriosis-associated pain symptoms after 3 months and 6 months of Dienogest treatment measured using a questionnaire |
| Secondary outcome measures | Tolerability and safety aspects after the use of Dienogest for 6 months measured using routine controls |
| Overall study start date | 28/09/2023 |
| Completion date | 01/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 65 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 01/01/2025 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Rama IV Road, Pathumwan district
Bangkok
10330
Thailand
Sponsor information
Industry
287 Liberty Square 21st Floor, room no.2101
Bangkok
10500
Thailand
| Phone | +662 6311952 |
|---|---|
| enrique.calvo@exeltis.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 11/03/2024 | No | No |
Additional files
Editorial Notes
11/03/2024: Trial's existence confirmed by Institutional Review Board, Faculty of Medicine, Chulalongkorn University
