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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: Ipsen
• Treatments: Triptorelin Pamoate

Criteria

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