NCT01615211

Randomized Study of Letrozole and Trilostane for Medical Abortion

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Kristina Gemzell Danielsson · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Medical Abortion, Complete or Unspecified, Without Complication

Interventions

Type	Name	Description
DRUG	Letrozole	Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
DRUG	Trilostane	Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-06-08
• Last updated: 2015-05-18

Locations

1 site across 1 country: Sweden