Symptomatic or Large Uterine FibroidsPhase 1NCT00945360
Aromatase Inhibitors for Treatment of Uterine Leiomyomas
A Phase 1 study testing Letrozole (aromatase inhibitor) in people with Symptomatic or Large Uterine Fibroids, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Read more about this study
- Who is it for?
- Ages 50 to 55 years, women only
- Conditions the study is for
- Symptomatic or Large Uterine Fibroids
- What is being tested?
- Letrozole (aromatase inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteLebanon
- Study dates
- Mar 2011to May 2011
- Phase
- Phase 1
- 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 50 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms
Who cannot join
- Women <50 years of age
- Postmenopausal women
- Women with impaired renal function
- Oral treatment with any type of estrogen or progesterone more recently than 1 month
- History of venous thromboembolism
- Any contraindication for Magnetic Resonance Imaging (MRI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.
Read the detailed description
Fibroids (leiomyomas) are benign tumors that originate in the musculature of the uterus. They are the most common cause for removal of the uterus in women. Surgery is the final definitive treatment of fibroids. However, surgery is relatively risky. Hence, a few medical therapies have been tried for women who wish to preserve their uterus. However, most of those therapies have side effects that prohibit their routine use. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor ( such as Femara) in the treatment of fibroids. To the best of our knowledge, this drug has not been studied yet in the management of fibroid of the uterus apart from one case report.
The objective of the current study is to assess the effect of aromatase inhibitors, specifically Femara (letrozole) on the size of fibroids in women around menopause. We are hoping that by decreasing their size, we could avoid having patients undergo surgery. The data generated is invaluable in that sense.
- Conditions
- Symptomatic or Large Uterine Fibroids
- Being tested
- Letrozole (aromatase inhibitor)
- Keywords
- Leiomyoma, perimenopause, aromatase inhibitor
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole (aromatase inhibitor)Drug
Also called Letrozole
Letrozole at a dose of 2.5 mg/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| aromatase inhibitors: Letrozole | Experimental | All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks. Receives: Drug: Letrozole (aromatase inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole.
Measured: 2 months and 6 months following treatment
Secondary outcomes (4)
Improvement in symptoms
Measured: 2 and 6 months following treatment
Need for a surgical intervention
Measured: 2 and 6 months following treatment
Improvement in the hemoglobin levels
Measured: 2 and 6 months following treatment
Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis
Measured: 2 and 6 months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Inability to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic or Large Uterine FibroidsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Anwar H Nassar, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945360
- Sponsor's protocol ID
- OGY.AN.08
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatase Inhibitors for the Prevention of the Growth of Uterine Leiomyomas in Perimenopausal Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT00945360
- Acronym / sponsor ID
- OGY.AN.08
- Conditions
- Symptomatic or Large Uterine Fibroids
- Keywords
- Leiomyoma, perimenopause, aromatase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Jul 2009 (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.
Fibroids are benign tumors that might results in bleeding. Surgery is their definitive treatment. Some medical therapies have been tried for women who wish to preserve their uterus. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor (such as Femara) in the treatment of fibroids. This study is conducted to assess the effect of Femara (letrozole) on the size of fibroids in women around menopause.
Detailed description
Fibroids (leiomyomas) are benign tumors that originate in the musculature of the uterus. They are the most common cause for removal of the uterus in women. Surgery is the final definitive treatment of fibroids. However, surgery is relatively risky. Hence, a few medical therapies have been tried for women who wish to preserve their uterus. However, most of those therapies have side effects that prohibit their routine use. Recent reports have demonstrated a role for a new category of drugs called aromatase inhibitor ( such as Femara) in the treatment of fibroids. To the best of our knowledge, this drug has not been studied yet in the management of fibroid of the uterus apart from one case report.
The objective of the current study is to assess the effect of aromatase inhibitors, specifically Femara (letrozole) on the size of fibroids in women around menopause. We are hoping that by decreasing their size, we could avoid having patients undergo surgery. The data generated is invaluable in that sense.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aromatase inhibitors: Letrozole | Experimental | Drug: Letrozole (aromatase inhibitor)All consenting patients will be started on Letrozole at a dose of 2.5 mg/day for 8 weeks. |
Who may qualify
- Ages
- 50 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Perimenopausal women (≥ 50 years) with symptomatic uterine leiomyomas (menometrorrhagia, pressure symptoms, urinary retention, pelvic pain) or those with large leiomyomas ≥ 7 cms
Key exclusion criteria (6 listed)
- Women <50 years of age
- Postmenopausal women
- Women with impaired renal function
- Oral treatment with any type of estrogen or progesterone more recently than 1 month
- History of venous thromboembolism
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 (aromatase inhibitor)Also: LetrozoleLetrozole at a dose of 2.5 mg/day for 8 weeks. | Drug | aromatase inhibitors: Letrozole |
Primary outcome
The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole.
Time frame: 2 months and 6 months following treatment
4 secondary outcomes
Improvement in symptoms
Time frame: 2 and 6 months following treatment
Need for a surgical intervention
Time frame: 2 and 6 months following treatment
Improvement in the hemoglobin levels
Time frame: 2 and 6 months following treatment
Development of side effects: hot flushes, nausea,vomiting, headache, thrombophlebitis
Time frame: 2 and 6 months following treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
Anwar H Nassar, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Letrozole (aromatase inhibitor) in people with Symptomatic or Large Uterine Fibroids, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 6 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: withdrawn, as of the sponsor's last update on 13 Jul 2012. 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 Lebanon. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
The primary end point of this study will be the baseline to end point percent difference in leiomyoma volume at 2 months and 6 months following treatment with Letrozole. (time frame: 2 months and 6 months following treatment). 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 13 Jul 2012.