Randomized Study of Letrozole and Trilostane for Medical Abortion

Phase 2

Terminated

• Conditions: Medical Abortion, Complete or Unspecified, Without Complication
• Interventions: Drug: Trilostane; Drug: Letrozole

• Registration Number: NCT01615211
• Lead Sponsor: Kristina Gemzell Danielsson

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trilostane	Trilostane	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	Letrozole	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

Primary Outcome Measures

Name	Time	Method
efficacy	4 weeks	Evaluation of complete abortion by clinical judgement and ultrasonography

Secondary Outcome Measures

Name	Time	Method
Acceptability	1 week, 2 weeks and 4 weeks	questionnaire. Preferred future method of medical abortion.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden