Randomized Study of Letrozole and Trilostane for Medical Abortion

This study is currently recruiting participants.

Verified June 2012 by Karolinska Institutet

Sponsor:

Collaborators:

Karolinska Institutet

The University of Hong Kong

Information provided by (Responsible Party):

Kristina Gemzell Danielsson, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01615211

First received: June 4, 2012

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 4, 2012

Last Updated Date

June 7, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Evaluation of complete abortion by clinical judgement and ultrasonography

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01615211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Acceptability [ Time Frame: 1 week, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]

questionnaire. Preferred future method of medical abortion.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Randomized Study of Letrozole and Trilostane for Medical Abortion

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Medical Abortion, Complete or Unspecified, Without Complication

Intervention ^ICMJE

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

Other Name: Brand name Femar
Drug: Trilostane
Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice

Other Name: Brand name Modrenal

Study Arm (s)

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.

Intervention: Drug: Trilostane
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

Intervention: Drug: Letrozole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kristina Gemzell Danielsson, professor	+46-8-51772128	kristina.gemzell@ki.se
Contact: Helena Kopp Kallner, MD	+46-70-4402070	helena.kopp-kallner@ds.se

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01615211

Other Study ID Numbers ^ICMJE

W300TL

Has Data Monitoring Committee

Yes

Responsible Party

Kristina Gemzell Danielsson, Karolinska Institutet

Study Sponsor ^ICMJE

Kristina Gemzell Danielsson

Collaborators ^ICMJE

Karolinska Institutet
The University of Hong Kong

Investigators ^ICMJE

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

Information Provided By

Karolinska Institutet

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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