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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02636972




Registration number
NCT02636972
Ethics application status
Date submitted
6/12/2015
Date registered
22/12/2015
Date last updated
22/12/2015

Titles & IDs
Public title
The Progression From Dysmenorrhoea to Chronic Pelvic Pain
Scientific 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.
Secondary ID [1] 0 0
PPAI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysmenorrhoea 0 0
Pelvic Pain 0 0
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - OCPs

Group 1 - Mild or absent dysmenorrhoea and no other pelvic pain symptoms without contraceptive pill use.

Group 2A - History of mild or absent dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills).

Group 2B - History of severe dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills).

Group 3 - Severe dysmenorrhoea but without chronic pelvic pain and without contraceptive pill use.

Group 4 - Severe dysmenorrhoea but without chronic pelvic pain and with contraceptive pill use (Participants already using contraceptive pills).

Group 5 - Chronic pelvic pain and severe dysmenorrhoea without contraceptive pill use

Group 6 - Chronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills).


Treatment: Drugs: OCPs
Participants in the contraceptive pill groups can use any one of the following contraceptive pills:
Oestradiol valerate and dienogest, drospirenone and ethinyl estradiol , ethinyloestradiol and levonorgestrel, cyproterone and ethinyl estradiol, ethinylestradiol and norethisterone, Nomegestrol Acetate and Oestradiol and Ethinyl Estra
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reactivity of stimulated isolated peripheral blood immune cells
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Levels of anxiety and depression using the DAS21
Timepoint [2] 0 0
2 weeks

Eligibility
Key inclusion criteria
- Age between 16 to 35 years old
Minimum age
16 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Irregular menstrual cycles

- Use of any reproductive hormonal preparations (other than the combined oral
contraceptive pill), thyroxine, insulin or corticosteroids

- Presence of an inflammatory process, or clinically significant infection in the 4
weeks

- Clinically significant renal, hepatic, cardiac, auto-immune disease

- Current use of immunosuppressant medication such as hydroxychloroquine, methotrexate
or azathioprine

- Inability to read or comprehend the written information provided

- Current use of medications known to affect TLR responsiveness including amitriptyline
or minocycline

- Current use of any analgesics, including non-steroidal anti-inflammatory medications
and opioids for 5 drug half-lives prior to the day of testing

- Current or previous pregnancy

- Body Mass index less than 18 or more than 30

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2016
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
PARC, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02636972
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan Evans, MBBS
Address 0 0
PARC Research Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02636972