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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ipsen
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00735852
First received: August 14, 2008
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Endometriosis
Drug: Decapeptyl SR 11.25mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • To assess the impact of treatment with Decapeptyl SR plus Livial on CCPP throughout the 24 month treatment period [ Time Frame: baseline, month 12, month 24 and month 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To asses effect of Decapeptyl SR on pain, disability, overall health status and quality of life [ Time Frame: baseline and 3 monthly until study end ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Decapeptyl SR 11.25mg
    11.25 mgs, Intra muscular (IM) every 3 months for 2 years
    Other Name: Triptorelin acetate
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 health questionnaires completed, blood samples collected and any prior or concomitant medications will be noted. Bone density will be determined using a DEXA scan performed in the interval between the screening and baseline visits. One month after the screening visit, patients will return to the clinic for the baseline visit. At this visit a physical examination and urine pregnancy test will be performed, vital signs measured, specific validated questionnaires on pain and endometriosis related health will be completed and symptoms of oestrogen deficiency will be documented. Patients who are still considered to be eligible for the trial will receive an injection of Decapeptyl SR 11.25 mg, and will be dispensed sufficient Livial 2.5 mg tablets to last until the next study visit. Patients will return for repeat Decapeptyl SR injections every 3 months until Month 21 at which time the last Decapeptyl SR injection will be administered. At these visits patients will also be dispensed further supplies of Livial.

Follow−up assessments will be performed during the treatment period 3, 6, 12, 18 and 24 months after the baseline visit. A final follow−up assessment will be conducted 6 months after stopping treatment. At each follow−up visit specific validated questionnaires on pain and endometriosis related health will be collected and symptoms of oestrogen deficiency will be noted. Physical examination, vital signs, bone density assessment and haematology and biochemistry analysis will be repeated at selected timepoints.

Health economic data will be collected at all study visits.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735852

Contacts
Contact: Tin C Li, Professor 0114 2268330 tin.c.li@sth.nhs.uk
Contact: Sheila P Duffy 0114 2268333 sheila.duffy@sth.nhs.uk

Locations
United Kingdom
Academic Unit of Reproductive and Developmental Medicine, Jessop Wing, Tree Root Walk Recruiting
Sheffield, South Yorkshire, United Kingdom, S13 8LE
Principal Investigator: Tin C Li, Professor         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Ipsen
Investigators
Principal Investigator: Tin C Li, Professor Sheffield Teaching Hopsitals Trust
  More Information

No publications provided

Responsible Party: Professor T C Li, Sheffield teaching Hopsitals Trust
ClinicalTrials.gov Identifier: NCT00735852     History of Changes
Other Study ID Numbers: STH 14404
Study First Received: August 14, 2008
Last Updated: July 19, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
endometriosis
chronic cyclical pelvic pain

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014