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| Name | Class |
|---|---|
| Pamela Youde Nethersole Eastern Hospital | OTHER |
| The Queen Elizabeth Hospital | OTHER |
| Kwong Wah Hospital | OTHER |
| Princess Margaret Hospital, Canada |
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Endometriosis is a chronic inflammatory disease that affects approximately 10-15% of women of reproductive age. Symptoms include dysmenorrhoea, chronic pelvic pain, dyspareunia and infertility. Removal of the endometriotic cyst (chocolate cyst) by surgery is a well-established treatment for symptomatic relief. However, recurrence of endometriotic cyst after surgical removal of the cyst is up to 30-50% after ovarian surgery. Oral contraceptive pills for 18-24 months after the surgery is widely used as a postoperative hormonal therapy because it has been shown to reduce the chance of recurrence of the endometriotic cyst, but recurrence is still high even after taking oral contraceptive pills.
Letrozole is an aromatase inhibitor. There are some preliminary reports that letrozole can cause shrinkage of endometriotic cysts and improve endometriosis-related pelvic pain by reducing oestrogen level, inflammation and stem cell recruitment that may be important in recurrence of endometriotic cyst. This is a randomized double-blinded placebo-controlled trial. The aim of this study is to assess whether taking letrozole in addition to oral contraceptive pills in the first 6 months after laparoscopic surgery (key-hole surgery) to remove the endometriotic cyst can reduce the risk of recurrence compared to oral contraceptive pills alone. The study also involves laboratory parts from a small portion of the endometriotic cyst specimens (removed during laparoscopy ovarian cystectomy) and endometrial biopsy (if the patient agrees) to assess the role of stem cells in the pathogenesis of endometriotic cysts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Experimental | They will be given letrozole 2.5mg daily on top of combined oral contraceptive (COC) pills (Microgynon 30, which contains 30mcg ethinyloestradiol and 150 mcg levonorgestrel) orally for 6 months after laparoscopic ovarian cystectomy, followed by COC pills alone subsequently as routine |
|
| Standard treatment | Placebo Comparator | They will be given placebo tablets (which will be identical to letrozole) on top of COC pills (Microgynon 30, which contains 30mcg ethinyloestradiol and 150 mcg levonorgestrel) orally for 6 months after laparoscopic ovarian cystectomy, followed by COC pills alone subsequently |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole 2.5mg daily for 6 months |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of endometrioma | the presence of ovarian cysts with the typical sonographic criteria of endometriomas and a diameter of ≥30 mm after previous complete ovarian cystectomy, to be measured by a transvaginal or transrectal ultrasound transducer | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endometriosis Health Profile Questionnaire (EHP-30) score | a validated disease-specific health related quality of life patient self-reported scale for endometriosis used to measure the effects that endometriosis can have on the women's lives and the effectiveness of medical and surgical therapies for endometriosis on their quality of life | 6 months, 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | 000000 | Hong Kong |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| OTHER |
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| Other |
Placebo |
|
| Non-menstrual pelvic pain (chronic pelvic pain, deep dyspareunia) and dysmenorrhoea measured by a 10cm visual analogue pain scale (VAS) | 0-100 | 6 months, 12 months, 24 months |
| Menstrual regularity | menstrual chart | 6 months, 12 months, 24 months |
| Use of additional analgesics | 6 months, 12 months, 24 months |
| Side effects/ adverse events | Number of women with side effects/ adverse events | 6 months, 12 months, 24 months |
| Need for further surgery for endometriosis | Number of women who required further surgery for endometriosis | 6 months, 12 months, 24 months |
| Kwong Wah Hospital | Not yet recruiting | Hong Kong | Hong Kong |
|
| Pamela Youde Nethersole Eastern Hospital | Not yet recruiting | Hong Kong | Hong Kong |
|
| Princess Margaret Hospital | Not yet recruiting | Hong Kong | Hong Kong |
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| Queen Elizabeth Hospital | Not yet recruiting | Hong Kong | Hong Kong |
|
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |