Status:
COMPLETED
Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Ipsen
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
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 chr...
Detailed Description
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 he...
Eligibility Criteria
Inclusion
- aged between 18 and 45 years inclusive
- have a clinical diagnosis of chronic cyclical pelvic pain of at least 6 months duration (with or without evidence of endometriosis)
- have had investigations for possible endometriosis within three years prior to screening visit
- had regular menstrual cycles (24-42 days) for 3 months prior to screening
- treatment with LHRHa is indicated
- must be able to understand and be willing to comply with the requirements of the protocol
Exclusion
- treated with any LHRHa within 6 months prior to screening
- treated with danazol, gestrinone or cyproterone acetate within 6 months prior to screening
- used cyclical progesterones or combined oral contraceptives within one full menstrual cycle prior to screening
- treated with any other medication other than analgesics within 3 months prior to screening
- continuous or acyclical pelvic pain
- known metabolic bone disease
- abnormal full blood count or liver or renal function at screening or within 6 months
- unexplained vaginal bleeding
- bone mineral density age adjusted T Score of -2 or below at screening visit.
- any other medical condition or abnormality that would impact on the safety or efficacy of the study treatment
- receiving treatment with coumarin or indanedione derivatives
- known contraindication or allergy or hypersensitivity to test compounds
- pregnancy or lactation
- planning a pregnancy within 31 months of screening
- of child bearing potential and unwilling to use adequate barrier contraception for the duration of the study
- received any investigational drug therapy within 30 days prior to the study
- has previously entered the study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00735852
Start Date
December 1 2008
End Date
May 1 2016
Last Update
April 18 2019
Active Locations (1)
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1
Academic Unit of Reproductive and Developmental Medicine, Jessop Wing, Tree Root Walk
Sheffield, South Yorkshire, United Kingdom, S13 8LE