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Trial record 6 of 14 for:    Triptorelin | endometriosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735852
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Decapeptyl SR 11.25mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Triptorelin

Intervention Details:
  • Drug: Decapeptyl SR 11.25mg
    11.25 mgs, Intra muscular (IM) every 3 months for 2 years
    Other Name: Triptorelin acetate

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00735852

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United Kingdom
Academic Unit of Reproductive and Developmental Medicine, Jessop Wing, Tree Root Walk
Sheffield, South Yorkshire, United Kingdom, S13 8LE
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
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Principal Investigator: Mostafa Metwally, Mr Sheffield Teaching Hopsitals Trust
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust Identifier: NCT00735852    
Other Study ID Numbers: STH 14404
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
chronic cyclical pelvic pain
Additional relevant MeSH terms:
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Triptorelin Pamoate
Pelvic Pain
Neurologic Manifestations
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents