NCT02636972

The Progression From Dysmenorrhoea to Chronic Pelvic Pain

The Progression From Dysmenorrhoea to Chronic Pelvic Pain: Investigation of the Role of Chronic Inflammatory Pain Phenotype in Peripheral Blood as a Potential Biomarker.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: University of Adelaide · Academic / Other
• Sex: Female
• Age: 16 Years – 35 Years
• Healthy volunteers: Accepted

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

Conditions

• Dysmenorrhoea
• Pelvic Pain
• Chronic Pain

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-12-22
• Last updated: 2025-03-28

Locations

1 site across 1 country: Australia