| - candidate number | 9132 |
| - NTR Number | NTR2760 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 17-feb-2011 |
| - Secondary IDs | 2010/103 METc VUmc |
| - Public Title | Behandeling van endometriose met groene thee: Een dubbel blind gerandomiseerde placebo gecontroleerde pilot studie. |
| - Scientific Title | Treatment of endometriosis with epigallocatechin gallate: A double-blind randomized placebo-controlled pilot trial. |
| - ACRONYM | TEE-study |
| - hypothesis | To evaluate if Epigallocatechin gallate (EGCG) is an effective treatment for pain in endometriosis patients by using Visual Analogue Scores (VAS). |
| - Healt Condition(s) or Problem(s) studied | Endometriosis, Epigallocatechin gallate, Green tea |
| - Inclusion criteria | 1. Signed and dated informed consent; 2. The use of oral contraceptives; 3. Pain associated with visually proven endometriosis determined by diagnostic laparoscopy; 4. Negative pregnancy test; 5. Threshold for pelvic painscore: Minimum of 40 mm on VAS during menstruation at screening; 6. Transvaginal ultrasound within the last 3 months; 7. Good general health (except for endometriosis). |
| - Exclusion criteria | 1. Previous/ current use of hormonal agents including GnRH agonists (not within 6 cycles), progestins (not within 3 cycles), hormonal contraception (not within 1 cycle), IUD (mirena), specific oral contraceptives (Diane 35 and three phase oral contraceptives, not within one cycle); 2. Positive pregnancy test; 3. Breastfeeding; 4. Blood coagulation disorders; 5. Liver dysfunction; 6. Usage of any prescription drug; 7. Contra indication for usage of ibuprofen. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2011 |
| - planned closingdate | 1-mrt-2013 |
| - Target number of participants | 60 |
| - Interventions | Epigallocatechin gallate capsules 225 mg 3 times a day (total dosage a day of 675 mg) for three months. |
| - Primary outcome | 1. To evaluate if the VAS pain scores are lower in patients using EGCG versus placebo treatment; 2. To evaluate if serum Ca-125 level is lower in patients using EGCG versus placebo treatment; 3. To investigate if the total dosage of rescue pain medication is lower in patients using EGCG versus placebo treatment. |
| - Secondary outcome | 1. To investigate if the Biberoglu & Behrman severity profile is lower in patients using EGCG versus placebo treatment; 2. To investigate if the menstrual bloodloss is lower in patients using EGCG versus placebo treatment. |
| - Timepoints | T=0: Before start with medication at cycle day 2 of the first menstrual cycle; T=1: 28 days after visit 1; T=2: 56 days after visit 1; T=3: 84 days after visit 1. |
| - Trial web site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Dr. P.G.A. Hompes |
| - CONTACT for SCIENTIFIC QUERIES | Dr. P.G.A. Hompes |
| - Sponsor/Initiator | VU University Medical Center, Department of Obstetrics and Gynaecology |
| - Funding (Source(s) of Monetary or Material Support) | VU University Medical Center, Department of Obstetrics and Gynaecology |
| - Publications | N/A |
| - Brief summary | A double-blind randomized placebo-controlled pilot trial to evaluate the effect of Epigallocatechin Gallate on VAS pain scores in patients with endometriosis. |
| - Main changes (audit trail) | |
| - RECORD | 17-feb-2011 - 10-jun-2012 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl