A prospective single-centre single-arm open-label study of the long-term use of a LHRH agonist (Decapeptyl SR 11.25mg) in combination with livial add-back therapy in the management of chronic cyclical pelvic pain in pre-menopausal women

• Register: ISRCTN
• Last refreshed on: 17 June 2019
• Main ID: ISRCTN19040577
• Date of registration: 29/04/2010
• Prospective Registration: No
• Primary sponsor: Sheffield Teaching Hospitals NHS Trust (UK)
• Public title: A prospective single-centre single-arm open-label study of the long-term use of a LHRH agonist (Decapeptyl SR 11.25mg) in combination with livial add-back therapy in the management of chronic cyclical pelvic pain in pre-menopausal women
• Scientific title: A prospective single-centre single-arm open-label study of the long-term use of a LHRH agonist (Decapeptyl SR 11.25mg) in combination with livial add-back therapy in the management of chronic cyclical pelvic pain in pre-menopausal women
• Date of first enrolment: 11/12/2008
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN19040577
• Study type: Interventional
• Study design: Open-label interventional treatment trial (Treatment)
• Phase: Phase IV

Countries of recruitment

United Kingdom

Contacts

• Name: Sheila Duffy

Key inclusion & exclusion criteria

Inclusion criteria:
Patients must satisfy all of the following entry criteria before they will be allowed to participate in the study:
1. The patient must have given written (personally signed and dated) informed consent given before completing any study-related procedure, which means any assessment or evaluation that would not have formed part of their normal medical care
2. The patient must be aged between 18 and 45 years inclusive, female only
3. The patient must have a clinical diagnosis of CCPP of at least 6 months duration (with or without evidence of endometriosis)
4. The patient must have had a laparoscopy within three years prior to the Screening visit
5. The patient must have had regular menstrual cycles (between 24 and 42 days) for the 3 months prior to screening
6. Treatment with a LHRHa is indicated for the patient
7. The patient must be able to understand, and willing to comply with the requirements of the protocol

Exclusion criteria:
Patients who satisfy any of the following criteria must not be included in the study:
1. The patient has been treated with any LHRHa within 6 months prior to screening
2. The patient has been treated with Danazol, gestrinone or cyproterone acetate within the 6 months prior to screening or anticipated requirement during the study
3. The patient has used cyclical progestogens or combined oral contraceptives within one full menstrual cycle (including a spontaneous bleed) prior to screening, or anticipated requirement for these treatments during the study period
4. The patient is treated with any other medication for CCPP (other than simple analgesics) within three months prior to screening
5. The patient has continuous or acyclic pelvic pain
6. The patient has known metabolic bone disease
7. The patient has an abnormal full blood count or liver or renal function at screening or within the 6 months prior to screening
8. The patient has unexplained vaginal bleeding
9. The patient has a bone mineral density age adjusted T-Score of -2 or below at the screening visit
10. The patient has any other medical condition or abnormality that in the opinion of the investigator would impact upon the safety or efficacy of the study treatment or any study assessments
11. The patient is receiving concomitant treatment with coumarin or indanedione derivatives
12. The patient has a known contraindication, allergy or hypersensitivity to any of the test compounds or materials (including both Decapeptyl SR and Livial)
13. The patient is pregnant or lactating. Female patients of child-bearing potential (i.e. who are not surgically sterile) must have a negative urine pregnancy test at the baseline visit.
14. The patient is planning a pregnancy within 31 months of screening
15. The patient is of child-bearing potential and is unwilling to use adequate barrier contraception for the duration of the study
16. The patient has received any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period
17. The patient has previously entered this study


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Topic: Reproductive Health and Childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
Signs and Symptoms
Abdominal and pelvic pain

Intervention(s)

This is a single-centre, single-arm, open-label study to assess the efficacy and safety of the extended use (24 months treatment) of Decapeptyl SR (11.25 mg every 3 months) when administered in combination with Livial tablets (2.5 mg daily) for the treatment of women with CCPP. Follow up length: 30 months.

Primary Outcome(s)

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

Secondary Outcome(s)

1. To assess the change in CCPP as assessed using the Short Form McGill Pain Questionnaire (SF-MPQ)
2. To assess the change in concomitant analgesic use at all assessment timepoints
3. To assess the change in Health-related Quality of Life (HR-QOL) at all assessment timepoints
4. To assess the change in overall health status at all assessment timepoints in comparison to baseline
5. To assess the change in the Disability Score and the overall Chronic Pain Grade (0 - IV)
6. To assess the change in the scores for each individual domain of the CPG Questionnaire

Secondary ID(s)

6899

2007-001159-20

Source(s) of Monetary Support

Ipsen Pharma (UK)

Ethics review

Status:
Approval date:
Contact:

MREC approved on the 05/08/2008, ref: 08/H1308/150

Results

• Results available: Yes
• Date Completed: 30/06/2016