Randomized Study of Letrozole and Trilostane for Medical Abortion

NCT01615211 | Terminated Phase 2 DMC

• 1 other identifier: W300TL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Medical Abortion, Complete or Unspecified, Without Complication

Keywords

Abortion; medical abortion; termination of pregnancy; Mifepristone; misoprostol; letrozole; trilostane; femara; Modrenal

Outcome Measures

Primary Outcomes (1)

• efficacy

  Evaluation of complete abortion by clinical judgement and ultrasonography

  4 weeks

Secondary Outcomes (1)

• Acceptability

  1 week, 2 weeks and 4 weeks

Study Arms (3)

Standard treatment

NO INTERVENTION

patients will receive standard treatment with 200mg Mifepristone and after 36-48 hours 800 mcg of misoprostol vaginally

trilostane

ACTIVE COMPARATOR

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

Letrozole

ACTIVE COMPARATOR

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

Interventions

Letrozole DRUG

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

Also known as: Brand name Femar

Letrozole

Trilostane DRUG

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

Also known as: Brand name Modrenal

trilostane

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study

You may not qualify if:

• Any ongoing medication or medical condition smoking \>20 cigarettes per day BMI \>30

Sponsors & Collaborators

• Kristina Gemzell Danielsson: lead
• Karolinska Institutet: collaborator
• The University of Hong Kong: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17177, Sweden

Location

MeSH Terms

Interventions

Letrozole; trilostane

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kristina Gemzell Danielsson, professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Helena Kopp Kallner, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 8, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

SE (1)