Extrait

Background and study aims Decapeptyl is a synthetic (man-made) hormone that stops the ovaries producing the hormone oestrogen. It can be used to treat disorders that are dependent on oestrogen being present, such as endometriosis and chronic cyclical pelvic pain (CCPP). Endometriosis is the presence of endometrial tissue outside the uterus, most commonly in the pelvis and abdomen. This tissue is affected by cyclical changes in hormones like the usual endometrial tissue. This tissue grows further when supplied with oestrogen, forming lesions which cause pain. It is thought that if the surges in hormones are suppressed, the lesions won't be triggered and pain won't occur. Decapeptyl is currently licensed for short-term use (up to 6 months) for CCPP, but not for long-term use because oestrogen depletion can cause unwanted side effects such as hot flushes, vaginal dryness, headache and brittle bones. One proposed strategy to limit the unwanted side effects is to 'add back' oestrogen at a constant low dose – not enough to promote any flares in CCPP, but enough to prevent or significantly reduce the side effects. The aim of this study is to test the safety and effectiveness of an injection of Decapeptyl every 3 months when given with a daily hormone replacement therapy (HRT) tablet (Livial) for 2 years. Who can participate? Women aged between 18 and 45 with a clinical diagnosis of CCPP of at least 6 months duration (with or without evidence of endometriosis). What does the study involve? There will be 11 visits to hospital during the course of the study. At the first visit your medical history and medication use will be recorded and you will be asked to complete two pain questionnaires and three quality of life questionnaires. A blood sample will be taken and a bone scan will be performed. At the next visit a physical examination and urine pregnancy test will be performed, your blood pressure and pulse will be measured, you will complete pain and quality of life questionnaires, and symptoms of oestrogen deficiency will be noted. You will be given an injection of Decapeptyl and will be given enough Livial tablets to last until the next visit. You will then return for repeat Decapeptyl injections every 3 months until Month 21, at which time the last Decapeptyl injection will be administered. At these visits you will also be given further supplies of Livial. There will be follow-up visits 6, 12, 18 and 24 months after the first injection. A final follow-up assessment will be conducted 6 months after stopping treatment (at Month 30). At each follow-up visit pain and general health questionnaires will be completed and symptoms of oestrogen deficiency will be noted. Physical examinations, blood pressure and pulse measurements, bone scans and blood samples will be repeated at months 12, 24 and 30. Other medications and adverse events are recorded at each visit. What are the possible benefits and risks of participating? Decapeptyl has a number of reported side effects. At the beginning of treatment the symptoms of endometriosis (pelvic pain, dysmenorrhoea) may get worse. These symptoms should disappear in one or two weeks. Genital bleeding may occur in the month following the first injection. Adverse reactions could include hot flushes, sweating, sleep disturbances, headache, mood changes, vaginal dryness, painful sexual intercourse, and decreased libido. Transient pain, redness or local inflammation at the injection site may occur. The following adverse reactions have been observed during clinical trials with other formulations of the drug: breast pain, muscle cramps, joint pain, weight gain, nausea, abdominal pain or discomfort, weakness, increased blood pressure, episodes of blurred or abnormal vision, rash, swelling, and hair loss. A small loss in bone density occurs during 6 months of Decapeptyl treatment, but clinical data suggests that this loss is reversible. Livial also has a number of reported side effects. Occasionally, vaginal bleeding or spotting may occur, mainly during the first months of treatment. Other adverse events that have been observed occasionally include: dizziness, rash, itching, headache, migraine, visual disturbances (including blurred vision), stomach upset, depression, swelling, joint pain, muscle pain, and changes in liver function. Where is the study run from? Sheffield Teaching Hospitals NHS Trust (UK). When is the study starting and how long is it expected to run for? From December 2008 to June 2016. Who is funding the study? Ipsen Pharma (UK). Who is the main contact? Sheila Duffy

Critère d'inclusion

• Topic: Reproductive health and childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth

Liens

• isrctn
• ictrp