No registrations found.
ID
Source
Brief title
Health condition
Endometriosis
Endometriose
Epigallocatechin gallate
Epigallocatechine gallaat
EGCG
Green tea
Groene thee
Sponsors and support
Department of Obstretics and Gynaecology
Department of Obstretics and Gynaecology
Intervention
Outcome measures
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.
Background summary
A double-blind randomized placebo-controlled pilot trial to evaluate the effect of Epigallocatechin Gallate on VAS pain scores in patients with endometriosis.
Study objective
To evaluate if Epigallocatechin gallate (EGCG) is an effective treatment for pain in endometriosis patients by using Visual Analogue Scores (VAS).
Study design
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.
Intervention
Epigallocatechin gallate capsules 225 mg 3 times a day (total dosage a day of 675 mg) for three months.
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
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
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2632 |
| NTR-old | NTR2760 |
| Other | METc VUmc : 2010/103 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |