Treatment of Endometriosis with Epigallocatechin gallate: a double-blind randomized placebo-controlled crossover pilot trial.

Completed

Conditions: appearance of endometrial tissue outside the womb.
Endometriosis
10038612

Registration Number: NL-OMON39170

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 7

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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in VAS pain scores after EGCG versus placebo treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. The difference in the dimension Pain of the EHP-30 questionnaire after<br /><br>using EGCG versus placebo treatment.<br /><br>2. The difference in serum Ca-125 level after EGCG versus placebo treatment.<br /><br>3. The difference in total amount of rescue medication during EGCG versus<br /><br>placebo treatment.<br /><br>4. The difference in Biberoglu & Behrman severity after EGCG versus placebo<br /><br>treatment.<br /><br>5. The total amount of bloodloss during EGCG versus placebo treatment.</p><br>