Overview

This trial is active, not recruiting.

Conditions dysmenorrhoea, pelvic pain, chronic pain
Treatment ocps
Sponsor University of Adelaide
Start date November 2014
End date January 2016
Trial size 56 participants
Trial identifier NCT02636972, PPAI-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Mild or absent dysmenorrhoea and no other pelvic pain symptoms without contraceptive pill use.
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).
ocps
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
History of severe dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills).
ocps
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
Severe dysmenorrhoea but without chronic pelvic pain and without contraceptive pill use.
Severe dysmenorrhoea but without chronic pelvic pain and with contraceptive pill use (Participants already using contraceptive pills).
ocps
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
Chronic pelvic pain and severe dysmenorrhoea without contraceptive pill use
Chronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills).
ocps
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

Measure
Reactivity of stimulated isolated peripheral blood immune cells
time frame: 2 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 16 years up to 35 years old.

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

Additional Information

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.
Principal investigator Susan Evans, MBBS
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Adelaide.