Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Adenomyosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with LNG-IUS

Placement of levonorgestrel-releasing intrauterine system

Group Type OTHER

Placement of levonorgestrel-releasing intrauterine system

Intervention Type PROCEDURE

All the patients accepted treatment of levonorgestrel-releasing intrauterine system

Interventions

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Placement of levonorgestrel-releasing intrauterine system

All the patients accepted treatment of levonorgestrel-releasing intrauterine system

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No