Randomized Study of Letrozole and Trilostane for Medical Abortion
This study is currently recruiting participants.
Verified June 2012 by Karolinska Institutet
Sponsor:
Kristina Gemzell Danielsson
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
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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
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:
|
Mifepristone Trilostane Misoprostol Dihydrotestosterone Letrozole Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Androgens Hormones Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on May 16, 2013