Gonadotroph AdenomasPhase 2LARNCT00929669
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
A Phase 2 study testing pasireotide LAR in people with Gonadotroph Adenomas, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonadotroph Adenomas
- What is being tested?
- pasireotide LAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gonadotroph adenoma
Who cannot join
- visual impairment attributable to the adenoma
- radiation therapy
- active gallbladder disease
- uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.
Read the detailed description
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.
- Conditions
- Gonadotroph Adenomas
- Being tested
- pasireotide LAR
- Keywords
- pituitary tumor, endocrine
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pasireotide LARDrug
Also called SOM230
pasireotide LAR 80 mg IM once a month
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide LAR | Experimental | 80 mg IM once monthly Receives: Drug: pasireotide LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.
Measured: 12 months
Secondary outcomes (1)
Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
Serum FSH (mIU/mL) will be measured at baseline and then monthly for the 12 months of the study to determine if serum FSH concentrations decrease by 20%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: unable to identify a third subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gonadotroph AdenomasStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J. Snyder, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929669
- Sponsor's protocol ID
- 809652
- Acronym
- LAR
- Status last verified
- Oct 2017
- First submitted
- 23 Jun 2009
- Last updated
- 28 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study
- ClinicalTrials.gov ID
- NCT00929669
- Acronym / sponsor ID
- LAR / 809652
- Conditions
- Gonadotroph Adenomas
- Keywords
- pituitary tumor, endocrine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to identify a third subject
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Jun 2009 (estimated)
- Results
- Posted 28 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.
Detailed description
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 receptors, and gonadotroph adenomas express these receptors. For this study, three subjects who have gonadotroph adenomas, as judged by a macroadenoma of the pituitary and elevated serum FSH concentration, will be treated with a long-acting form of pasireotide once a month for one year. The effect of pasireotide on the size of the adenoma will be determined by MRI, and FSH secretion will be judged by the serum concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pasireotide LAR | Experimental | Drug: pasireotide LAR80 mg IM once monthly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gonadotroph adenoma
Key exclusion criteria (4 listed)
- visual impairment attributable to the adenoma
- radiation therapy
- active gallbladder disease
- uncontrolled diabetes
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 |
|---|---|---|
| pasireotide LARAlso: SOM230pasireotide LAR 80 mg IM once a month | Drug | Pasireotide LAR |
Primary outcome
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
Time frame: 12 months
MRI of the pituitary will be performed at baseline, Month 6 and Month 12 to demonstrate a decrease of ≥3 mm in at least two of three dimensions on MRI (cephalocaudal, transverse, and posterior-anterior). The outcome measure is defined as the number of participants who demonstrated a ≥3 mm decrease in adenoma size in two dimensions.
1 secondary outcome
Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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.
Peter J. Snyder, MD principal investigator
University of Pennsylvania
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 pasireotide LAR in people with Gonadotroph Adenomas, run by University of Pennsylvania at 1 site in United States.
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 4 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 28 Nov 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI (time frame: 12 months). 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 28 Nov 2017.