NCT02636972

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

December 6, 2015

Last Update Submit

March 26, 2025

Conditions

DysmenorrhoeaPelvic PainChronic Pain

Keywords

TLR2TLR4BiomarkerTLR responsivenessPeripheral blood responsivenessInflammatory pain

Outcome Measures

Primary Outcomes (1)

  • Reactivity of stimulated isolated peripheral blood immune cells

    To determine if there are different inflammatory pain phenotypes between young women with either severe dysmenorrhoea alone, chronic pelvic pain from controls with mild or no dysmenorrhoea from the collected peripheral blood immune cells (assessed by cytokine output).

    2 weeks

Secondary Outcomes (2)

  • Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire

    2 weeks

  • Levels of anxiety and depression using the DAS21

    2 weeks

Study Arms (7)

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).

Drug: OCPs

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).

Drug: OCPs

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).

Drug: OCPs

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).

Drug: OCPs

Interventions

OCPsDRUG

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

Group 2AGroup 2BGroup 4Group 6

Eligibility Criteria

Age16 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Nulliparous women in good general health (can experience dysmenorrhoea (abscent, mild or severe), with or without pelvic pain and with or without contraceptive pill use)

You may qualify if:

  • Age between 16 to 35 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PARC, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample retained for future analysis (may include DNA analysis)

MeSH Terms

Conditions

DysmenorrheaPelvic PainChronic Pain

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Susan Evans, MBBS

    PARC Research Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBS, FRANZCOG, FFPMANZCA, GAICD

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 22, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)