Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Adenomyosis Clinical Trial

Official title:

Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027648
• Other study ID #: PUMCH-OBGYN-2014
• Status: Completed
• Phase: N/A
• First received: January 15, 2017
• Last updated: January 19, 2017
• Start date: December 2006
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis.

Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.

Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea

Second outcome measures: carrying status of IUS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: January 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women with regular menses

• Adenomyosis diagnosed via transvaginal ultrasound

• With severe dysmenorrhea (VAS = 7) and/or menorrhea (pictorial chart scores >100)

• Duration of placement > 12 months

• Size of uterus by physical examination less than uterus of 12-week pregnancy

Exclusion Criteria:

• Desire for pregnancy or lactation

• With diagnosis of malignancies or precancerous lesions

• Acceptance of laparotomy

• Contraindication of placing levonorgestrel-releasing intrauterine system

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Procedure:
• Placement of levonorgestrel-releasing intrauterine system
All the patients accepted treatment of levonorgestrel-releasing intrauterine system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system	visual analogue scale for pain	5 years after placement of levonorgestrel-releasing intrauterine system
Secondary	unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system		5 years after placement of levonorgestrel-releasing intrauterine system
Secondary	spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system		5 years after placement of levonorgestrel-releasing intrauterine system
Secondary	improvement of symptoms of adenomyosis assessed by verbal rating scales for pain	verbal rating scales for pain	5 years after placement of levonorgestrel-releasing intrauterine system
Secondary	improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea	hemoglobin for menorrhea	5 years after placement of levonorgestrel-releasing intrauterine system
Secondary	improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea	visual analogue scale for pain	5 years after placement of levonorgestrel-releasing intrauterine system