No access to study drug Trilostan. Company closed down
A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy
Sponsor study identifier
interventional
36
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
October 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
June 4, 2012
Actual (reported)June 8, 2012
Actual (reported)October 2013
Actual (reported)October 2013
Actual (reported)efficacy
Evaluation of complete abortion by clinical judgement and ultrasonography
4 weeks
Acceptability
1 week, 2 weeks and 4 weeks
patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally
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.
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
Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice
Karolinska University Hospital
Stockholm, 17177, Sweden
Kristina Gemzell Danielsson, professor
Karolinska Institutet
Helena Kopp Kallner, MD
Karolinska Institutet
First Submitted
June 4, 2012
First Posted
June 8, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma
Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)
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Study Completion
October 2013
Actual (reported)Last Updated
May 18, 2015
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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