Overview

Pretreatment With Mifepristone Prior to Mirena Insertion

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
Female
Summary
Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea and reduce bleeding irrregularities during the initial months of Mirena use.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Karolinska Institutet
Treatments:
Levonorgestrel
Mifepristone
Criteria
Inclusion criteria:

- Pre-menopausal women, >/= 18 years of age.

- Desire of Mirena for contraception

- Good general health (as judged by; general physical examination

- Willing and able to participate after giving informed consent

Exclusion criteria:

- Any hormonal treatment or IUD use within 2 months prior to study start

- History of malignant disorder of the breast

- Any contraindication to mifepristone

- Pregnancy or breast feeding within 2 months prior to study start