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Randomized Study of Letrozole and Trilostane for Medical Abortion

NCT01615211 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-05-18

No results posted yet for this study

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.

Conditions

  • Medical Abortion, Complete or Unspecified, Without Complication

Interventions

DRUG

Letrozole

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

DRUG

Trilostane

Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • The University of Hong Kong

    collaborator OTHER

  • Kristina Gemzell Danielsson

    lead OTHER

Principal Investigators

  • Kristina Gemzell Danielsson, professor · Karolinska Institutet

  • Helena Kopp Kallner, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615211 on ClinicalTrials.gov