Medical Abortion, Complete or Unspecified, Without Complication
Conditions
Keywords
Abortion, medical abortion, termination of pregnancy, Mifepristone, misoprostol, letrozole, trilostane, femara, Modrenal
Brief summary
In menstruation an effective shedding of the endometrial lining occurs. Both progesterone and estrogen levels fall sharply at this time. During medical abortion the endometrial shedding is sometimes ineffective causing an incomplete abortion which may cause prolonged bleeding or require surgical intervention. In medical abortion a progesterone antagonist is used as treatment but the estrogen levels are not targeted. The investigators wish to explore whether addition of letrozole or trilostane which target estrogen levels can lead to a more effective shedding of the endometrial lining.
Interventions
DRUGLetrozole
Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
DRUGTrilostane
Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice
Sponsors
Karolinska Institutet
The University of Hong Kong
Kristina Gemzell Danielsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study
Exclusion criteria
* Any ongoing medication or medical condition smoking \>20 cigarettes per day BMI \>30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy | 4 weeks | Evaluation of complete abortion by clinical judgement and ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 1 week, 2 weeks and 4 weeks | questionnaire. Preferred future method of medical abortion. |
Countries
Sweden
Outcome results
None listed