Randomized Study of Letrozole and Trilostane for Medical Abortion

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy

Conditions
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Medical Abortion, Complete or Unspecified, Without Complication

Intervention / Treatment
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* Drug: Letrozole
* Drug: Trilostane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment<br>patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally | |
| Active Comparator: trilostane<br>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<br>* Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice<br>* Other names: Brand name Modrenal;|
| Active Comparator: Letrozole<br>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<br>* Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets<br>* Other names: Brand name Femar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy | Evaluation of complete abortion by clinical judgement and ultrasonography | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | questionnaire. Preferred future method of medical abortion. | 1 week, 2 weeks and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion, medical abortion, termination of pregnancy, Mifepristone, misoprostol, letrozole, trilostane, femara, Modrenal