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
ID
Bron
Verkorte titel
Aandoening
irregular bleeding
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the effect of oral estradiol (started at least 6 months after LNG-IUS insertion) on irregular bleeding
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
baseline, 3 months and 12 months
Onderzoeksproduct en/of interventie
2mg estradiol for 6 weeks
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8007 |
| Ander register | METC MMC : N17.070 |