Severe and Recurrent EndometriosisPhase 2NCT00240942
Letrozole in the Treatment of Severe and Recurrent Endometriosis
A Phase 2 study testing Letrozole in people with Severe and Recurrent Endometriosis, run by Novartis Pharmaceuticals.
Trial summary
Endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. This study will investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition effective in reducing measurable endometriosis… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe and Recurrent Endometriosis
- What is being tested?
- Letrozole
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Jun 2006
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal women > 18 years of age.
- Laparoscopic and Histologically confirmed diagnosis of moderate or severe endometriosis according rASRM-Score III and IV
- BMI less than 40 kg/m².
- Patient is sexually abstinent or using mechanical (condoms, diaphragms) or sterilization methods of contraception and is willing to continue using them throughout the study.
- Patient is willing and able to comply with study requirements.
- Written informed consent.
Who cannot join
- Endometriosis stage I-II acc. according to rASRM
- Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
- Significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range.
- Patient desires pregnancy for the duration of the study, is pregnant or breast feeding.
- GnRH therapy during the last 6 months
- Use of hormonal contraception, selective estrogen receptor modulators, progestins, estrogens, steroids, or ovulation induction in the 4 weeks prior to inclusion into the study.
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- Untreated abnormal pap smear or other gynecologic condition.
- History of venous thrombosis events including deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis.
- History of stroke, complicated migraine, or documented transient ischemic attack.
- Known hypersensitivity to any ingredient of the study medication.
- Treatment with other aromatase inhibitors
- Other investigational drugs within the past 30 days and the concomitant use of investigational drugs.
- History of non-compliance to medical regimens, and patients who are considered potentially unreliable.
- Additional protocol-defined inclusion / exclusion criteria may apply
About this study
Endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. This study will investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition effective in reducing measurable endometriosis lesions and in reducing pain in patients with active endometriosis which were pretreated with GnRH analogs for 2 months.
- Conditions
- Severe and Recurrent Endometriosis
- Being tested
- Letrozole
- Keywords
- Endometriosis, GnRH analog, Aromataseinhibitor, Letrozole
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks
Secondary outcomes (4)
Duration of clinical response
Time to progression of the disease
Correlation of tumour response with pretreatment ER/PR status
Histological grade and aromatase levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startOct 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe and Recurrent EndometriosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240942
- Sponsor's protocol ID
- CFEM345ADE04
- Status last verified
- Apr 2012
- First submitted
- 14 Oct 2005
- Last updated
- 26 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole in the Treatment of Severe and Recurrent Endometriosis
- ClinicalTrials.gov ID
- NCT00240942
- Acronym / sponsor ID
- CFEM345ADE04
- Conditions
- Severe and Recurrent Endometriosis
- Keywords
- Endometriosis, GnRH analog, Aromataseinhibitor, Letrozole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 18 Oct 2005 (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.
Endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. This study will investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition effective in reducing measurable endometriosis lesions and in reducing pain in patients with active endometriosis which were pretreated with GnRH analogs for 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Premenopausal women > 18 years of age.
- Laparoscopic and Histologically confirmed diagnosis of moderate or severe endometriosis according rASRM-Score III and IV
- BMI less than 40 kg/m².
- Patient is sexually abstinent or using mechanical (condoms, diaphragms) or sterilization methods of contraception and is willing to continue using them throughout the study.
- Patient is willing and able to comply with study requirements.
Key exclusion criteria (14 listed)
- Endometriosis stage I-II acc. according to rASRM
- Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
- Significant abnormalities in the physical or laboratory examination including renal and liver function more than twice the normal range.
- Patient desires pregnancy for the duration of the study, is pregnant or breast feeding.
- GnRH therapy during the last 6 months
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 |
|---|---|---|
| Letrozole | Drug | – |
Primary outcome
Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 weeks
4 secondary outcomes
Duration of clinical response
Time to progression of the disease
Correlation of tumour response with pretreatment ER/PR status
Histological grade and aromatase levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole in people with Severe and Recurrent Endometriosis, run by Novartis Pharmaceuticals.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 26 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rates (CR, PR, NC, PD) during treatment of advanced endometrial cancer assessed by tumor marker assessments and radiologic imaging at week 12 then q 12 weeks x 1 year then q 16 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 26 Apr 2012.