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Randomized Study of Letrozole and Trilostane for Medical Abortion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Karolinska Institutet.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Medical Abortion, Complete or Unspecified, Without Complication
Drug: Letrozole
Drug: Trilostane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • efficacy [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Evaluation of complete abortion by clinical judgement and ultrasonography


Secondary Outcome Measures:
  • Acceptability [ Time Frame: 1 week, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
    questionnaire. Preferred future method of medical abortion.


Estimated Enrollment: 36
Study Start Date: May 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Brand name Femar

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615211

Contacts
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

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17177
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   
Principal Investigator: Kristina Gemzell Danielsson, professor         
Sub-Investigator: Helena Kopp Kallner, MD         
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
  More Information

No publications provided

Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01615211     History of Changes
Other Study ID Numbers: W300TL
Study First Received: June 4, 2012
Last Updated: June 7, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Abortion
medical abortion
termination of pregnancy
Mifepristone
misoprostol
letrozole
trilostane
femara
Modrenal

Additional relevant MeSH terms:
Letrozole
Trilostane
Abortifacient Agents
Abortifacient Agents, Steroidal
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014