No registrations found.
ID
Source
Brief title
Health condition
irregular bleeding
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the effect of oral estradiol (started at least 6 months after LNG-IUS insertion) on irregular bleeding
Secondary outcome
- The effect of oral estradiol use on the incidence of premature removal of the LNG-IUS.
- The occurrence of adverse events due to use of estradiol.
Background summary
The levonorgestrel-releasing Intrauterine System (LNG-IUS) releases levonorgestrel for five years. Irregular bleeding up to six months after insertion of the LNG-IUS often occurs. In some cases irregular bleeding continues after six months or returns over time. Up to 60% of women remove the LNG-IUS prematurely. An important reason for premature removal is occurrence of bleeding disturbances. The best treatment option for these bleeding disturbances is unknown.
To evaluate the effect of oral estradiol (started at least 6 months after LNG-IUS insertion) on irregular bleeding. Secondary objectives include the effect of estradiol use on incidence of premature removal of the LNG-IUS and the occurrence of adverse events due to use of estradiol.
Study objective
We hypothesize that the use of oral estradiol is effective in women with irregular bleeding with a LNG-IUS in situ for more than 6 months
Study design
baseline, 3 months and 12 months
Intervention
2mg estradiol for 6 weeks
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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8007 |
| Other | METC MMC : N17.070 |