Randomized Study of Letrozole and Trilostane for Medical Abortion

Medical Abortion, Complete or Unspecified, Without Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01615211
• Other study ID #: W300TL
• Status: Terminated
• Phase: Phase 2
• First received: June 4, 2012
• Last updated: May 15, 2015
• Start date: May 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Abortion, Complete or Unspecified, Without Complication

Intervention

Drug:
• Letrozole
Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
• Trilostane
Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Kristina Gemzell Danielsson	Karolinska Institutet, The University of Hong Kong

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy	Evaluation of complete abortion by clinical judgement and ultrasonography	4 weeks	No
Secondary	Acceptability	questionnaire. Preferred future method of medical abortion.	1 week, 2 weeks and 4 weeks	No