The Womens wellness through Intrauterine Neuroimmune modulation study: The effect of a new intrauterine device on pelvic pain in women.

Phase 1

Recruiting

• Conditions: Pelvic Pain; Dysmenorrhoea; Reproductive Health and Childbirth; Reproductive Health and Childbirth - Menstruation and menopause; Reproductive Health and Childbirth - Contraception

• Registration Number: ACTRN12623000675628
• Lead Sponsor: Alyra Biotech Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-22
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

*Is in good general health.
*Agrees to have an IUD for ~84 days.
*Agrees to take oral temperature recordings.
*Has a history of regular menstrual cycles (i.e. every 21-35 days).
*Has a uterus with no significant abnormalities.
*Has a minimum of one vaginal birth
*Agrees to record their symptoms daily and use of medications on a study specific APP.
*Does not plan to become pregnant during their study involvement.

Exclusion Criteria

*Know sensitivity, intolerance, or allergy to non-steroidal anti-inflammatory drugs, paracetamol, ibuprofen, levonorgestrel, amitriptyline, or any components of the intrauterine device.
*Has a positive urine drug screen.
*Has a significant gynaecological condition.
*Has undergone a hysterectomy or oophorectomy.
*Has recurrent or current pelvic infections.
*Has severe arterial disease.
*Has uncontrolled epilepsy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified