Randomized Study of Letrozole and Trilostane for Medical Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01615211
Recruitment Status : Terminated (No access to study drug Trilostan. Company closed down)
First Posted : June 8, 2012
Last Update Posted : May 18, 2015
Karolinska Institutet
The University of Hong Kong
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet

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 Type : Interventional  (Clinical Trial)
Estimated 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 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

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 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

Primary Outcome Measures :
  1. efficacy [ Time Frame: 4 weeks ]
    Evaluation of complete abortion by clinical judgement and ultrasonography

Secondary Outcome Measures :
  1. Acceptability [ Time Frame: 1 week, 2 weeks and 4 weeks ]
    questionnaire. Preferred future method of medical abortion.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01615211

Karolinska University Hospital
Stockholm, Sweden, 17177
Sponsors and Collaborators
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

Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet Identifier: NCT01615211     History of Changes
Other Study ID Numbers: W300TL
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
medical abortion
termination of pregnancy

Additional relevant MeSH terms:
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Luteolytic Agents
Menstruation-Inducing Agents