Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02636972
Status:
UNKNOWN
Last Update Posted:
2015-12-22
First Post:
2015-12-06
Brief Title:
The Progression From Dysmenorrhoea to Chronic Pelvic Pain
Sponsor:
University of Adelaide
Organization:
University of Adelaide
Study Overview
Official Title:
The Progression From Dysmenorrhoea to Chronic Pelvic Pain Investigation of the Role of Chronic Inflammatory Pain Phenotype in Peripheral Blood as a Potential Biomarker
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a cross-sectional observational study
For participants resident in Adelaide South Australia
The study consists of 3 visits to the Pain and Anaesthesia Research Clinic PARC within the Royal Adelaide Hospital RAH
A total of 56 participants will be recruited for this study
For participants resident in Adelaide South Australia
The study consists of 3 visits to the Pain and Anaesthesia Research Clinic PARC within the Royal Adelaide Hospital RAH
A total of 56 participants will be recruited for this study
Detailed Description:
The study will involve a screening visit followed by two visits to PARC for blood sampling and questionnaires
At the baseline visit blood samples to assess biomarkers and confirm hormonal status will be taken
From screening until the final study visit a total of approximately 120 mL in blood samples will be taken from each participant
The study aims to further knowledge in the presence of severe pelvic pain in young women which is an area that has been under-researched with regard to its impact on society
The study proposes to enroll 7 groups of 8 healthy nulliparous women aged 18-35 with the following characteristics
Mild or absent dysmenorrhoea pain scale 0-3 and no other pelvic pain symptoms 3 groups
Group 1 without contraceptive pill use
Group 2A contraceptive pill user and with a history of mild or absent dysmenorrhoea prior to pill use
Group 2B contraceptive pill user and with a history of severe dysmenorrhoea pain scale 7-10 prior to pill use
Severe dysmenorrhoea pain scale 7-10 but without chronic pelvic pain 2 groups
Group 3 without contraceptive pill use
Group 4 contraceptive pill user
Chronic pelvic pain and severe dysmenorrhoea 2 groups
Group 5 without contraceptive pill use
Group 6contraceptive pill user
At the baseline visit blood samples to assess biomarkers and confirm hormonal status will be taken
From screening until the final study visit a total of approximately 120 mL in blood samples will be taken from each participant
The study aims to further knowledge in the presence of severe pelvic pain in young women which is an area that has been under-researched with regard to its impact on society
The study proposes to enroll 7 groups of 8 healthy nulliparous women aged 18-35 with the following characteristics
Mild or absent dysmenorrhoea pain scale 0-3 and no other pelvic pain symptoms 3 groups
Group 1 without contraceptive pill use
Group 2A contraceptive pill user and with a history of mild or absent dysmenorrhoea prior to pill use
Group 2B contraceptive pill user and with a history of severe dysmenorrhoea pain scale 7-10 prior to pill use
Severe dysmenorrhoea pain scale 7-10 but without chronic pelvic pain 2 groups
Group 3 without contraceptive pill use
Group 4 contraceptive pill user
Chronic pelvic pain and severe dysmenorrhoea 2 groups
Group 5 without contraceptive pill use
Group 6contraceptive pill user
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None