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The Progression From Dysmenorrhoea to Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT02636972
Recruitment Status : Unknown
Verified December 2015 by Dr Susan Evans, University of Adelaide.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Susan Evans, University of Adelaide

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.


Condition or disease Intervention/treatment
Dysmenorrhoea Pelvic Pain Chronic Pain Drug: OCPs

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 it's 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 6,contraceptive pill user

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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
Study Start Date : November 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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 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

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 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

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 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

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





Primary Outcome Measures :
  1. Reactivity of stimulated isolated peripheral blood immune cells [ Time Frame: 2 weeks ]
    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).


Secondary Outcome Measures :
  1. Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire [ Time Frame: 2 weeks ]
    Secondary efficacy end point

  2. Levels of anxiety and depression using the DAS21 [ Time Frame: 2 weeks ]
    Secondary efficacy end point


Biospecimen Retention:   Samples With DNA
Blood sample retained for future analysis (may include DNA analysis)


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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)
Criteria

Inclusion Criteria:

  • Age between 16 to 35 years old

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02636972


Locations
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Australia, South Australia
PARC, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
University of Adelaide
Investigators
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Principal Investigator: Susan Evans, MBBS PARC Research Clinic

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Responsible Party: Dr Susan Evans, MBBS, FRANZCOG, FFPMANZCA, GAICD, University of Adelaide
ClinicalTrials.gov Identifier: NCT02636972     History of Changes
Other Study ID Numbers: PPAI-001
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Susan Evans, University of Adelaide:
TLR2
TLR4
Biomarker
TLR responsiveness
Peripheral blood responsiveness
Inflammatory pain
Additional relevant MeSH terms:
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Chronic Pain
Pelvic Pain
Dysmenorrhea
Pain
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Menstruation Disturbances
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs