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

Treatment of endometriosis with epigallocatechin gallate: A double-blind randomized placebo-controlled pilot trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20203
Enrollment
60
Registered
2011-02-17
Start date
2011-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Endometriose Epigallocatechin gallate Epigallocatechine gallaat EGCG Green tea Groene thee

Interventions

Epigallocatechin gallate capsules 225 mg 3 times a day (total dosage a day of 675 mg) for three months.

Sponsors

VU university medical center Department of Obstretics and Gynaecology
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactP.G.A. Hompes

P.O. Box 7057

p.hompes@vumc.nl+31 (0)20 4444444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)