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

NCT00735852 | Completed Phase 4 DMC

• 1 other identifier: STH 14404
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Endometriosis

Keywords

endometriosis; chronic cyclical pelvic pain

Outcome Measures

Primary Outcomes (1)

• To assess the impact of treatment with Decapeptyl SR plus Livial on CCPP throughout the 24 month treatment period

  baseline, month 12, month 24 and month 30

Secondary Outcomes (1)

• To asses effect of Decapeptyl SR on pain, disability, overall health status and quality of life

  baseline and 3 monthly until study end

Interventions

Decapeptyl SR 11.25mg DRUG

11.25 mgs, Intra muscular (IM) every 3 months for 2 years

Also known as: Triptorelin acetate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Ipsen: collaborator

Study Sites (1)

Academic Unit of Reproductive and Developmental Medicine, Jessop Wing, Tree Root Walk

Sheffield, South Yorkshire, S13 8LE, United Kingdom

Location

Related Publications (1)

• Alshehre SM, Duffy S, Jones G, Ledger WL, Metwally M. A prospective, single-centre, single-arm, open label study of the long term use of a gonadotropin releasing hormone agonist (Triptorelin SR, 11.25 mg) in combination with Tibolone add-back therapy in the management of chronic cyclical pelvic pain. Reprod Biol Endocrinol. 2020 Apr 14;18(1):28. doi: 10.1186/s12958-020-00586-z.

  PMID: 32290838 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Mostafa Metwally, Mr

  Sheffield Teaching Hopsitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

GB (1)