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

What Was Tested

In this phase 4 trial, researchers set out to test Triptorelin for chronic pain: fibromyalgia & crps and endometriosis.

This will be for a 2 year period with a 6 month post treatment follow up.

The study aims to recruit 40 patients.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 31 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Triptorelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-12 with completion listed for 2016-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 1 secondary outcome, for example To asses effect of Decapeptyl SR on pain, disability, overall health status and quality of life.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Triptorelin in 31 people with chronic pain: fibromyalgia & crps.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, Chronic pain: fibromyalgia & CRPS research, Endometriosis research.