Treatment of irregular bleeding after insertion of the levonorgestrel-releasing Intrauterine System (LNG-IUS).
Recruiting
- Conditions
- irregular bleeding
- Registration Number
- NL-OMON25280
- Lead Sponsor
- Maxima Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Women with a LNG-IUS in situ for more than six months, who visit the outpatient clinic with bleeding disturbances and opt for a treatment with oral estradiol
Exclusion Criteria
- Women younger than 18 years
- Abnormal cervical cytology or malignancies of the uterus
- The presence of polyps, myomas on ultrasound
- A contra-indication for the use of estradiol (thrombosis or mamma carcinoma in patient history)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of oral estradiol (started at least 6 months after LNG-IUS insertion) on irregular bleeding
- Secondary Outcome Measures
Name Time Method - The effect of oral estradiol use on the incidence of premature removal of the LNG-IUS.<br>- The occurrence of adverse events due to use of estradiol.