The Progression From Dysmenorrhoea to Chronic Pelvic Pain

NCT ID: NCT02636972

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-01-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Group 1

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

No interventions assigned to this group

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).

OCPs

Intervention Type: 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

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).

OCPs

Intervention Type: 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

Group 3

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

No interventions assigned to this group

Group 4

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

OCPs

Intervention Type: 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

Group 5

Chronic pelvic pain and severe dysmenorrhoea without contraceptive pill use

No interventions assigned to this group

Group 6

Chronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills).

OCPs

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Adelaide

OTHER

Sponsor Role: lead

Responsible Party

Dr Susan Evans

MBBS, FRANZCOG, FFPMANZCA, GAICD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Evans, MBBS

Role: PRINCIPAL_INVESTIGATOR

PARC Research Clinic

Locations

PARC, Royal Adelaide Hospital

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

PPAI-001

Identifier Type: -

Identifier Source: org_study_id