A Phase 2 interventional study of Letrozole and Trilostane in Medical Abortion, Complete or Unspecified, Without Complication, sponsored by Kristina Gemzell Danielsson. Terminated at 1 site in Sweden. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-05-18.
Sponsored by Kristina Gemzell Danielsson · Phase 2, Interventional, and Treatment
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.
Kristina Gemzell Danielsson is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Trilostane
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
Drug: Letrozole
Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
Also known as: Brand name Femar
Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice
Also known as: Brand name Modrenal
efficacy
Evaluation of complete abortion by clinical judgement and ultrasonography
Time frame: 4 weeks
Acceptability
questionnaire. Preferred future method of medical abortion.
Time frame: 1 week, 2 weeks and 4 weeks
The record gives a start of May 2012, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Letrozole
Kristina Gemzell Danielsson