AcromegalyPhase 2NCT00315107
Estrogen Treatment in Acromegalic Women
A Phase 2 study testing Alesse in people with Acromegaly, run by Université de Montréal at 1 site in Canada.
Trial summary
Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acromegaly
- What is being tested?
- Alesse
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Aug 2007
- 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
- Women 18 years and older treated with somatostatin analogs
- Active acromegaly
Who cannot join
- Cardiovascular or cerebrovascular disease
- Thrombophlebitis or thromboembolism
- Breast cancer
- Non-controlled arterial hypertension
- Smoking
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHUM - Notre-Dame Hospital
Montreal, Quebec, H2L 4M1
Omar Serri, MD
About this study
Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.
Read the detailed description
This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.
- Conditions
- Acromegaly
- Being tested
- Alesse
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlesseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2006 (estimated)
- Study startMay 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Omar Serri, MD, Principal investigator, CHUM- Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315107
- Sponsor's protocol ID
- HND01
- Status last verified
- May 2006
- First submitted
- 13 Apr 2006
- Last updated
- 26 May 2006
- Results posted
- No
Publications
Kestler E, Ambrosio G, Hemming K, Hughes JP, Matute J, Moreno M, Madriz S, Walker D. An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: A stepped-wedge cluster randomized trial. Int J Gynaecol Obstet. 2020 Oct;151(1):109-116. doi: 10.1002/ijgo.13262. Epub 2020 Jul 27.
PubMed 32524605
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen Treatment in Acromegalic Women
- ClinicalTrials.gov ID
- NCT00315107
- Acronym / sponsor ID
- HND01
- Conditions
- Acromegaly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2006
- Study completion
- Aug 2007
- First posted
- 17 Apr 2006 (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.
Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.
Detailed description
This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women 18 years and older treated with somatostatin analogs
- Active acromegaly
Key exclusion criteria (6 listed)
- Cardiovascular or cerebrovascular disease
- Thrombophlebitis or thromboembolism
- Breast cancer
- Non-controlled arterial hypertension
- Smoking
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 |
|---|---|---|
| Alesse | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2006.
- Derived from this study: PubMed 32524605Kestler E, Ambrosio G, Hemming K, Hughes JP, Matute J, Moreno M, Madriz S, Walker D. An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: A stepped-wedge cluster randomized trial. Int J Gynaecol Obstet. 2020 Oct;151(1):109-116. doi: 10.1002/ijgo.13262. Epub 2020 Jul 27.
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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.
Omar Serri, MD principal investigator
CHUM- Endocrinology
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 Alesse in people with Acromegaly, run by Université de Montréal at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 26 May 2006. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar SERRI, MD (514-890-8000 ext. 25607, omar.serri@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00315107, which also lists 1 linked publication.
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 May 2006.