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Behandeling van endometriose met groene thee: Een dubbel blind gerandomiseerde placebo gecontroleerde pilot studie.


- candidate number9132
- NTR NumberNTR2760
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-feb-2011
- Secondary IDs2010/103 METc VUmc
- Public TitleBehandeling van endometriose met groene thee: Een dubbel blind gerandomiseerde placebo gecontroleerde pilot studie.
- Scientific TitleTreatment of endometriosis with epigallocatechin gallate: A double-blind randomized placebo-controlled pilot trial.
- ACRONYMTEE-study
- hypothesisTo 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) studiedEndometriosis, Epigallocatechin gallate, Green tea
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate1-mrt-2013
- Target number of participants60
- InterventionsEpigallocatechin gallate capsules 225 mg 3 times a day (total dosage a day of 675 mg) for three months.
- Primary outcome1. 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 outcome1. 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.
- TimepointsT=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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P.G.A. Hompes
- CONTACT for SCIENTIFIC QUERIESDr. 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
- PublicationsN/A
- Brief summaryA 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)
- RECORD17-feb-2011 - 10-jun-2012


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