The Progression From Dysmenorrhoea to Chronic Pelvic Pain

Completed

• Conditions: Chronic Pain; Dysmenorrhoea; Pelvic Pain
• Interventions: Drug: OCPs

• Registration Number: NCT02636972
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-22
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2A	OCPs	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	OCPs	History of severe dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills).
Group 4	OCPs	Severe dysmenorrhoea but without chronic pelvic pain and with contraceptive pill use (Participants already using contraceptive pills).
Group 6	OCPs	Chronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills).

Primary Outcome Measures

Name	Time	Method
Reactivity of stimulated isolated peripheral blood immune cells	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

Name	Time	Method
Levels of anxiety and depression using the DAS21	2 weeks	Secondary efficacy end point
Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire	2 weeks	Secondary efficacy end point

Trial Locations

Locations (1)

PARC, Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia