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Trial · Interventional

CompletedPhase 4Registry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
31 participants (actual)
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
Dec 2008
Primary completion
May 2016
Completion
May 2016
First posted
15 Aug 2008 (estimated)
Last update posted
18 Apr 2019
Conditions
Endometriosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082010201220142016
  1. Ph 4

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

    NCT00735852

    Dec 2008 to May 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Decapeptyl SR 11.25mgDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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 outcomes(1)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2020

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.

Alshehre et al. 2020Reproductive biology and endocrinology : RB&Ecited by 8

PMID 32290838PMC7155249DOI 10.1186/s12958-020-00586-zPUB-32290838

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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