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Completed

NCT Number: NCT02636972

The Progression From Dysmenorrhoea to Chronic Pelvic Pain

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.

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Key information

Conditions

Dysmenorrhoea Chronic Pain Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

16 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

PARC, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCPs

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2015
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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