Randomized Study of Letrozole and Trilostane for Medical Abortion

Sponsor

Kristina Gemzell Danielsson (Other)

Overall Status

Terminated

CT.gov ID

NCT01615211

Collaborator

Karolinska Institutet (Other), The University of Hong Kong (Other)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical Abortion, Complete or Unspecified, Without Complication	Drug: Letrozole Drug: Trilostane	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard treatment patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally
Active Comparator: 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.	Drug: Trilostane Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice Other Names: Brand name Modrenal
Active Comparator: 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	Drug: Letrozole Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets Other Names: Brand name Femar

Arm

Intervention/Treatment

No Intervention: Standard treatment

patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally

Active Comparator: 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.

Drug: Trilostane

Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice

Other Names:

Brand name Modrenal

Active Comparator: 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

Drug: Letrozole

Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets

Other Names:

Brand name Femar

Outcome Measures

Primary Outcome Measures

efficacy [4 weeks]
Evaluation of complete abortion by clinical judgement and ultrasonography

Secondary Outcome Measures

Acceptability [1 week, 2 weeks and 4 weeks]
questionnaire. Preferred future method of medical abortion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	17177

Sponsors and Collaborators

Kristina Gemzell Danielsson
Karolinska Institutet
The University of Hong Kong

Investigators

Principal Investigator: Kristina Gemzell Danielsson, professor, Karolinska Institutet
Principal Investigator: Helena Kopp Kallner, MD, Karolinska Institutet