To evaluate if Epigallocatechin gallate (EGCG) is an effective treatment for pain in endometriosis patients by using Visual Analogue Scores (VAS).
ID
Bron
Verkorte titel
Aandoening
Endometriosis
Endometriose
Epigallocatechin gallate
Epigallocatechine gallaat
EGCG
Green tea
Groene thee
Ondersteuning
Department of Obstretics and Gynaecology
Department of Obstretics and Gynaecology
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. To evaluate if the VAS pain scores are lower in patients using EGCG versus placebo treatment;<br>
2. To evaluate if serum Ca-125 level is lower in patients using EGCG versus placebo treatment;<br>
3. To investigate if the total dosage of rescue pain medication is lower in patients using EGCG versus placebo treatment.
Achtergrond van het onderzoek
A double-blind randomized placebo-controlled pilot trial to evaluate the effect of Epigallocatechin Gallate on VAS pain scores in patients with endometriosis.
Doel van het onderzoek
To evaluate if Epigallocatechin gallate (EGCG) is an effective treatment for pain in endometriosis patients by using Visual Analogue Scores (VAS).
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Epigallocatechin gallate capsules 225 mg 3 times a day (total dosage a day of 675 mg) for three months.
Publiek
P.G.A. Hompes
VU University Medical Center, Department of Reproductive Medicine
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444444
p.hompes@vumc.nl
Wetenschappelijk
P.G.A. Hompes
VU University Medical Center, Department of Reproductive Medicine
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444444
p.hompes@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2632 |
| NTR-old | NTR2760 |
| Ander register | METc VUmc : 2010/103 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |