Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women
This is a single-centre, open-label, within patient comparison study to assess the efficacy and safety of Decapeptyl SR when administered in combination with Livial for the treatment of women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post treatment follow up. The study aims to recruit 40 patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Single Centre, Single Arm, Open Label Study of the Long Term Use of a LHRA Agonist (Decapeptyl SR, 11.25mg) in Combination With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women|
- To assess the impact of treatment with Decapeptyl SR plus Livial on CCPP throughout the 24 month treatment period [ Time Frame: baseline, month 12, month 24 and month 30 ] [ Designated as safety issue: Yes ]
- To asses effect of Decapeptyl SR on pain, disability, overall health status and quality of life [ Time Frame: baseline and 3 monthly until study end ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Drug: Decapeptyl SR 11.25mg
A screening visit,will be performed and written informed consent will be obtained from the patient. In addition the patient's medical history will be checked, vital signs recorded, pain and general health questionnaires completed, blood samples collected and any prior or concomitant medications will be noted. Bone density will be determined using a DEXA scan performed in the interval between the screening and baseline visits. One month after the screening visit, patients will return to the clinic for the baseline visit. At this visit a physical examination and urine pregnancy test will be performed, vital signs measured, specific validated questionnaires on pain and endometriosis related health will be completed and symptoms of oestrogen deficiency will be documented. Patients who are still considered to be eligible for the trial will receive an injection of Decapeptyl SR 11.25 mg, and will be dispensed sufficient Livial 2.5 mg tablets to last until the next study visit. Patients will return for repeat Decapeptyl SR injections every 3 months until Month 21 at which time the last Decapeptyl SR injection will be administered. At these visits patients will also be dispensed further supplies of Livial.
Follow−up assessments will be performed during the treatment period 3, 6, 12, 18 and 24 months after the baseline visit. A final follow−up assessment will be conducted 6 months after stopping treatment. At each follow−up visit specific validated questionnaires on pain and endometriosis related health will be collected and symptoms of oestrogen deficiency will be noted. Physical examination, vital signs, bone density assessment and haematology and biochemistry analysis will be repeated at selected timepoints.
Health economic data will be collected at all study visits.
|Contact: Tin C Li, Professor||0114 firstname.lastname@example.org|
|Contact: Sheila P Duffy||0114 email@example.com|
|Academic Unit of Reproductive and Developmental Medicine, Jessop Wing, Tree Root Walk||Recruiting|
|Sheffield, South Yorkshire, United Kingdom, S13 8LE|
|Principal Investigator: Tin C Li, Professor|
|Principal Investigator:||Tin C Li, Professor||Sheffield Teaching Hopsitals Trust|