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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.
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)
Severe dysmenorrhoea (pain scale 7-10), but without chronic pelvic pain. (2 groups)
Chronic pelvic pain and severe dysmenorrhoea (2 groups)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
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| Group 5 | Chronic pelvic pain and severe dysmenorrhoea without contraceptive pill use |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire | Secondary efficacy end point | 2 weeks |
| Levels of anxiety and depression using the DAS21 | Secondary efficacy end point |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Susan Evans, MBBS | PARC Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PARC, Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D017699 | Pelvic Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Blood sample retained for future analysis (may include DNA analysis)
| Group 6 | Chronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills). |
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| 2 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |