A Prospective, Multi-centre, Single-Arm, Open Label Study of the Long term Use of a LHRH Agonist (Decapeptyl® SR, 11.25 mg) in Combination with Livial® Add-back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre-Menopausal Women - HRT Add-back therapy in the management of CCPP using Decapeptyl
- Conditions
- Chronic cyclical pelvic painMedDRA version: 13.1Level: LLTClassification code 10064189Term: Chronic pelvic pain syndromeSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 13.1Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders
- Registration Number
- EUCTR2007-001159-20-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
•The patient must have given written (personally signed and dated) informed consent given before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care.
•The patient must be aged between 18 and 45 years inclusive.
•The patient must have a clinical diagnosis of Chronic Cyclical Pelvic Pain (CCPP) of at least 6 months duration (with or without evidence of endometriosis).
•The patient must have had investigations for possible endometriosis within three years prior to the Screening visit.
•The patient must have had a regular menstrual cycles (between 24 and 42 days) for the 3 months prior to screening.
•Treatment with a LHRHa is indicated for the patient.
•The patient must be able to understand, and willing to comply with the requirements of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•The patient has been treated with any LHRHa within 6 months prior to screening.
•The patient has been treated with Danazol, gestrinone or cyproterone acetate within the 6 months prior to screening or anticipated requirement during the study.
•The patient has used cyclical progestogens or combined oral contraceptives within one full menstrual cycle (including a spontaneous bleed) prior to screening, or anticipated requirement for these treatments during the study period.
•The patient is treated with any other medication for CCPP (other than analgesics) within three months prior to screening.
•The patient has continuous or acyclic pelvic pain.
•The patient has known metabolic bone disease.
•The patient has an abnormal full blood count or liver or renal function at screening or within the 6 months prior to screening.
•The patient has unexplained vaginal bleeding.
•The patient has a bone mineral density age adjusted T-Score of -2 or below at the Screening visit.
•The patient has any other medical condition or abnormality that in the opinion of the investigator would impact upon the safety or efficacy of the study treatment or any study assessments.
•The patient is receiving concomitant treatment with coumarin or indanedione derivatives.
•The patient has a known contraindication, allergy or hypersensitivity to any of the test compounds or materials (including both Decapeptyl SR and Livial).
•The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile) must have a negative urine pregnancy test at the Baseline visit.
•The patient is planning a pregnancy within 31 months of screening.
•The patient is of child-bearing potential and is unwilling to use adequate barrier contraception for the duration of the study.
•The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
•The patient has previously entered this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the impact of treatment with Decapeptyl SR plus Tibolone on CCPP throughout the 24 month treatment period. Changes will be determined by comparison to Baseline. Pain will be assessed using the Chronic Pain Grade (CPG) Questionnaire;Secondary Objective: In addition to the CPG Questionnaire assessment of pain and quality of life will be undertaken using the following questionnaires<br>EHP-30<br>R-WHG<br>SF-12<br>SF-MPG<br><br>Safety Objectives<br>As well as assessing the overall safety of the intervention the change in lumbar spine and hip Bone Marrow Density will be assessed using dual-energy X-ray absorptiometry (DEXA) scans<br><br>Health Economics Objectives<br>Assess the costs associated with treatment, and assess its outcomes in terms of quality adjusted life years.<br>Assess the tentative incremental cost per quality adjusted life year for treatment by comparing cost and outcome on treatment to costs and outcomes in the year before treatment.<br>;Primary end point(s):
- Secondary Outcome Measures
Name Time Method