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No access to study drug Trilostan. Company closed down
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| The University of Hong Kong | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | No Intervention | patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally | |
| trilostane | Active Comparator | patients will receive Day 1: Mifepristone 200 mg and Trilostane 120mg 1 tablet twice and Day 2 Trilostane 240mg twice. On Day 3 800 mcg misoprostol will be given vaginally. |
|
| Letrozole | Active Comparator | Patients will receive on Day 1 Mifepristone 200mg and Letrozole 2,5mg 3 tablets and on Day 2 Letrozole 2,5mg 3 tablets. On day 3 800mcg of misoprostol will be given vaginally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | Evaluation of complete abortion by clinical judgement and ultrasonography | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | questionnaire. Preferred future method of medical abortion. | 1 week, 2 weeks and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Gemzell Danielsson, professor | Karolinska Institutet | Principal Investigator |
| Helena Kopp Kallner, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 17177 | Sweden |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| C009954 | trilostane |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Trilostane | Drug | Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice |
|
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |