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Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women

CompletedPhase 4NCT00735852
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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
Conditions
Interventions
  • Drug: Decapeptyl SR 11.25mg
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Ipsen
Start date
2008-12
Primary completion
2016-05
Sex
Female
Age range
from 18 Years to 45 Years
Results posted
No results posted in this snapshot
Countries
United Kingdom
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00735852