Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy?

Phase 3

Recruiting

• Conditions: Chronic Pelvic Pain in women in reproductive age; Reproductive Health and Childbirth - Menstruation and menopause; Reproductive Health and Childbirth - Contraception

• Registration Number: ACTRN12608000029392
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

All women with pelvic pain and or dysmenorrhoea

Exclusion Criteria

1. Acute pelvic inflammatory disease (PID) and or positive swab for Chlamydia +/- Gonorrhea
2. Chronic PID as defined by the presence of tubal damage (hydrosalpinx, hydrosalpinges) noted at surgery
3. Breast feeding women
4. Positive pregnancy urinary test or plan for a pregnancy within 12 months after enrollment
5. Previous hysterectomy
6. Contraindications to laparoscopy and/or anesthesia
7. Contraindication to the use of IUS according to WHO criteria
8. Hormonal treatment within the last three months
9. Malignancies
10. Known ovarian cysts other than endometriotic
10. Intention to use other medical treatment that may affect pelvic pain scores within 12 month
11. Use of hormonal treatments in the last three months prior to trial recruitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified