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

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12608000029392
• Date of registration: 18/01/2008
• Primary sponsor: University University of Sydney
• Public title: Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy?
• Scientific title: Mirena Intra-Uterine System: Does it Improve Long Term Symptoms in Women with Chronic Pelvic Pain and/or Endometriosis after Laparoscopy? A multicentre randomized placebo-controlled trial
• Date of first enrolment: 1/10/2009
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12608000029392.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Parallel

Countries of recruitment

Australia

Contacts

• Name: George Condous

• Name: George Condous

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Chronic Pelvic Pain in women in reproductive age

Intervention(s)

Mirena is a levonorgestrel-releasing intrauterine system, which consists of a T-shaped polyethylene frame (T-body) with a steroid reservoir. The reservoir consists of a cylinder, made of a mixture of levonorgestrel and silicone containing a total of 52 mg levonorgestrel. Low doses of levonorgestrel can be administered into the uterine cavity with the MIRENA intrauterine delivery system. Initially, levonorgestrel is released at a rate of approximately 20 µg/day. This rate decreases progressively to half that value after 5 years.

Primary Outcome(s)

Daily ratings (NRS) of dysmenorrhoea

Daily ratings using numerical rating scale (NRS) of pelvic pain

Secondary Outcome(s)

Quality of life using Endometriosis Health Profile (EHP)-30 with separate and total scores

Study specific adverse event questionnaires with direct questions and free text administered at the same time points as the EHP-30

Use of rescue analgesia/therapies including an NRS before use and a record of the indication

Source(s) of Monetary Support

University of Sydney

Secondary Sponsor(s)

Nepean Hospital

New secondary sponsor name. Please modify.