The Progression From Dysmenorrhoea to Chronic Pelvic Pain

University of Adelaide

Status

Completed

Conditions

Dysmenorrhoea

Pelvic Pain

Chronic Pain

Treatments

Drug: OCPs

Study type

Observational

Funder types

Other

Identifiers

NCT02636972

PPAI-001

Details and patient eligibility

About

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.

Full 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

Enrollment

56 patients

Sex

Female

Ages

16 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

56 participants in 7 patient groups

Group 1

Description:

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

Group 2A

Description:

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).

Treatment:

Drug: OCPs

Group 2B

Description:

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

Treatment:

Drug: OCPs

Group 3

Description:

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

Group 4

Description:

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

Treatment:

Drug: OCPs

Group 5

Description: