Treatment of irregular bleeding after insertion of the levonorgestrel-releasing Intrauterine System (LNG-IUS).

Treat-mi: Treatment of irregular bleeding after insertion of the levonorgestrel-releasing Intrauterine System (LNG-IUS).

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25280

Enrollment

100

Registered

2019-07-23

Start date

2017-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irregular bleeding

Interventions

2mg estradiol for 6 weeks

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
To evaluate the effect of oral estradiol (started at least 6 months after LNG-IUS insertion) on irregular bleeding	—

Secondary

Measure	Time frame
- 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.	—

Contacts

Public ContactTamara Oderkerk

Maxima Medisch Centrum

tamara.oderkerk@mmc.nl0408888384

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)