Randomized Study of Letrozole and Trilostane for Medical Abortion

May 15, 2015 updated by: Kristina Gemzell Danielsson

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17177
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy
Time Frame: 4 weeks
Evaluation of complete abortion by clinical judgement and ultrasonography
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 1 week, 2 weeks and 4 weeks
questionnaire. Preferred future method of medical abortion.
1 week, 2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristina Gemzell Danielsson

Collaborators

Karolinska Institutet
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W300TL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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