appearance of endometrial tissue outside the womb. Endometriosis
Conditions
Interventions
The dialy use of 3 capsules (or placebo or EGCG). The capsule should be taken
0,5-1 hour before breakfast, afternoon- and evening meal combined with a fair
amount of water during 4 subsequent months
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Signed and dated informed consent * Pain associated with visually proven endometriosis determined by diagnostic laparoscopy start of treatment (but not in 6 weeks prior to screening) * The use of oral contraceptives. * Persistent endometriosis related pain; Threshold for pelvic painscore: minimum of 40 mm on VAS * Transvaginal ultrasound within the last 3 months. * Good general health (except for endometriosis).
Exclusion criteria
Exclusion criteria: * Previous/current use of hormonal agents including: GnRH agonists (not within 6 cycles), progestins (not within 3 cycles), IUD (mirena), specific oral contraceptives (Diane 35 and three phase oral contraceptives, not within one cycle). * Breastfeeding * Blood coagulation disorders * Pregnancy * Liver dysfunction * Usage of any prescription drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in VAS pain scores after EGCG versus placebo treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference in the dimension *Pain* of the EHP-30 questionnaire after using EGCG versus placebo treatment. 2. The difference in serum Ca-125 level after EGCG versus placebo treatment. 3. The difference in total amount of rescue medication during EGCG versus placebo treatment. 4. The difference in Biberoglu & Behrman severity after EGCG versus placebo treatment. 5. The total amount of bloodloss during EGCG versus placebo treatment. | — |
Countries
Netherlands
Outcome results
None listed