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

June 4, 2012
June 7, 2012
May 2012
October 2013   (final data collection date for primary outcome measure)
efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Evaluation of complete abortion by clinical judgement and ultrasonography
Same as current
Complete list of historical versions of study NCT01615211 on ClinicalTrials.gov Archive Site
Acceptability [ Time Frame: 1 week, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
questionnaire. Preferred future method of medical abortion.
Same as current
Not Provided
Not Provided
 
Randomized Study of Letrozole and Trilostane for Medical Abortion
A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Medical Abortion, Complete or Unspecified, Without Complication
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
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
Sweden
 
NCT01615211
W300TL
Yes
Kristina Gemzell Danielsson, Karolinska Institutet
Kristina Gemzell Danielsson
  • Karolinska Institutet
  • The University of Hong Kong
Principal Investigator: Kristina Gemzell Danielsson, professor Karolinska Institutet
Principal Investigator: Helena Kopp Kallner, MD Karolinska Institutet
Karolinska Institutet
June 2012

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