DysmenorrhoeaNCT02636972
The Progression From Dysmenorrhoea to Chronic Pelvic Pain
An observational study of Dysmenorrhoea and Pelvic Pain, run by University of Adelaide at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhoea, Pelvic Pain, Chronic Pain
- What is being tested?
- OCPs
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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)
Who may be able to join
- Age between 16 to 35 years old
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Australia1 site
PARC, Royal Adelaide Hospital
Adelaide, South Australia, 5000
About this study
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.
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.
Read the 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
- Conditions
- Dysmenorrhoea, Pelvic Pain, Chronic Pain
- Being tested
- OCPs
- Keywords
- TLR2, TLR4, Biomarker, TLR responsiveness, Peripheral blood responsiveness, Inflammatory pain
- Medical subject headings
- Dysmenorrhea, Pelvic Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCPsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: OCPs | |
| 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). Receives: Drug: OCPs | |
| 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). Receives: Drug: OCPs | |
| 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). Receives: Drug: OCPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (2)
Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire
Secondary efficacy end point
Measured: 2 weeks
Levels of anxiety and depression using the DAS21
Secondary efficacy end point
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Susan Evans, University of Adelaide
- Investigators
- Susan Evans, MBBS, Principal investigator, PARC Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636972
- Sponsor's protocol ID
- PPAI-001
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2015
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02636972
- Acronym / sponsor ID
- PPAI-001
- Conditions
- Dysmenorrhoea, Pelvic Pain, Chronic Pain
- Keywords
- TLR2, TLR4, Biomarker, TLR responsiveness, Peripheral blood responsiveness, Inflammatory pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Mild or absent dysmenorrhoea and no other pelvic pain symptoms without contraceptive pill use. |
| Group 2A | – | Drug: OCPsHistory 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 | – | Drug: OCPsHistory of severe dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills). |
| Group 3 | – | –Severe dysmenorrhoea but without chronic pelvic pain and without contraceptive pill use. |
| Group 4 | – | Drug: OCPsSevere dysmenorrhoea but without chronic pelvic pain and with contraceptive pill use (Participants already using contraceptive pills). |
| Group 5 | – | –Chronic pelvic pain and severe dysmenorrhoea without contraceptive pill use |
| Group 6 | – | Drug: OCPsChronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills). |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (1 listed)
- Age between 16 to 35 years old
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCPsParticipants 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 | Drug | Group 2A, Group 2B, Group 4, Group 6 |
Primary outcome
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).
2 secondary outcomes
Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire
Time frame: 2 weeks
Levels of anxiety and depression using the DAS21
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Evans, MBBS principal investigator
PARC Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysmenorrhoea and Pelvic Pain, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactivity of stimulated isolated peripheral blood immune cells (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.