Medical Abortion, Complete or Unspecified, Without ComplicationPhase 2NCT01615211
Randomized Study of Letrozole and Trilostane for Medical Abortion
A Phase 2 study testing Letrozole and Trilostane in people with Medical Abortion, Complete or Unspecified, Without Complication, run by Kristina Gemzell Danielsson at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Medical Abortion, Complete or Unspecified, Without Complication
- What is being tested?
- Letrozole and Trilostane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study
Who cannot join
- Any ongoing medication or medical condition smoking >20 cigarettes per day BMI >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Letrozole, Trilostane
- Keywords
- Abortion, medical abortion, termination of pregnancy, Mifepristone, misoprostol, letrozole, trilostane, femara, Modrenal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Brand name Femar
Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
TrilostaneDrug
Also called Brand name Modrenal
Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
Evaluation of complete abortion by clinical judgement and ultrasonography
Measured: 4 weeks
Secondary outcomes (1)
Acceptability
questionnaire. Preferred future method of medical abortion.
Measured: 1 week, 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: No access to study drug Trilostan. Company closed down
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Abortion, Complete or Unspecified, Without ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristina Gemzell Danielsson
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, The University of Hong Kong
- Responsible party
- Sponsor-investigator, Kristina Gemzell Danielsson, Karolinska Institutet
- Investigators
- Kristina Gemzell Danielsson, professor, Principal investigator, Karolinska InstitutetHelena Kopp Kallner, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615211
- Sponsor's protocol ID
- W300TL
- Status last verified
- May 2015
- First submitted
- 4 Jun 2012
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of Two New Drug Combinations Fot the Termination fo Early Pregnancy
- ClinicalTrials.gov ID
- NCT01615211
- Acronym / sponsor ID
- W300TL
- Keywords
- Abortion, medical abortion, termination of pregnancy, Mifepristone, misoprostol, letrozole, trilostane, femara
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No access to study drug Trilostan. Company closed down
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kristina Gemzell DanielssonUniversity, hospital or other
- Collaborators
- Karolinska Institutet, The University of Hong Kong
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Trilostanepatients 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. |
| Letrozole | Active comparator | Drug: LetrozolePatients 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women aged 18-45 without any contraindication for treatment of any of the drugs involved in teh study
Key exclusion criteria (1 listed)
- Any ongoing medication or medical condition smoking >20 cigarettes per day BMI >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: Brand name FemarDay 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets | Drug | Letrozole |
| TrilostaneAlso: Brand name ModrenalDay 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice | Drug | trilostane |
Primary outcome
efficacy
Time frame: 4 weeks
Evaluation of complete abortion by clinical judgement and ultrasonography
1 secondary outcome
Acceptability
Time frame: 1 week, 2 weeks and 4 weeks
Results and safety
The study was stopped early (reason given: No access to study drug Trilostan. Company closed down). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Gemzell Danielsson, professor principal investigator
Karolinska Institutet
Helena Kopp Kallner, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole and Trilostane in people with Medical Abortion, Complete or Unspecified, Without Complication, run by Kristina Gemzell Danielsson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No access to study drug Trilostan. Company closed down). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.