AcromegalyPhase 2NCT02274311
Clomiphene Citrate for Treatment of Acromegaly
A Phase 2 study testing Clomiphene Citrate in people with Acromegaly, run by Felipe Henning Gaia Duarte.
Trial summary
To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist) Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Acromegaly
- What is being tested?
- Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Oct 2014
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with active acromegaly on regular use of a stable dose of Octreotide-LAR and/or cabergoline for at least one year,
- Insulin like growth factor 1 above the reference range during the last year of follow-up and
- testosterone levels within or below the third inferior tertile of normality.
Who cannot join
- radiotherapy in the last 10 years, previous venous embolism (including family members),
- previous prostatic cancer or symptomatic benign hypertrophy,
- triglyceride levels above 400 mg/dL,
- renal failure defined by estimative of renal filtration below 30 ml/min,
- liver disease defined by hepatic enzymes 3 times above normal limit,
- active oncologic disease in the last 10 years and previous cardiac or cerebrovascular disease.
About this study
Official title: Clomiphene Citrate for Treatment of Acromegaly Not Controlled by Conventional Therapies
To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)
Read the detailed description
Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients
Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.
The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.
In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.
- Conditions
- Acromegaly
- Being tested
- Clomiphene Citrate
- Keywords
- Acromegaly, SERM, Clomiphene
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene CitrateDrug
Also called Clomid; Serophene; Indux
Clomiphene citrate, 50 mg, orally for three months
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate | Experimental | Patients receiving clomiphene citrate Receives: Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-1 Levels
The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
Measured: Day 90
Secondary outcomes (2)
Testosterone Levels
The objective is to compare the change of testosterone value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
Measured: D90
PSA Levels
The objective is to compare the change of PSA value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2014
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 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Felipe Henning Gaia Duarte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Felipe Henning Gaia Duarte, University of Sao Paulo General Hospital
- Investigators
- Marcello D Bronstein, MD, PhD, Study chair, Unit of Neuroendocrinology, Discipline of Endocrinology, Department of Internal Medicine Clinical Hospital of the University of São Paulo Medical School, São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274311
- Sponsor's protocol ID
- ClomipheneAcro
- Status last verified
- Apr 2019
- First submitted
- 20 Oct 2014
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate for Treatment of Acromegaly Not Controlled by Conventional Therapies
- ClinicalTrials.gov ID
- NCT02274311
- Acronym / sponsor ID
- ClomipheneAcro
- Conditions
- Acromegaly
- Keywords
- Acromegaly, SERM, Clomiphene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Felipe Henning Gaia DuarteUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone receptor antagonist)
Detailed description
Acromegaly, a disease caused by a growth hormone secreting pituitary adenoma, results in reduced life span. Despite the many modalities available to treat this disease,as surgery, medical treatment and radiotherapy, uncontrolled disease persists in a significant portion of patients
Oral estrogens, alone or in combination with somatostatin receptor analogues, have been shown to control acromegaly in women. Selective estrogen receptor modulators (SERMs) resulted in similar effects in both genders. Clomiphene citrate, a SERM that increases luteinizing hormone and follicle stimulating hormone secretion, improves hypogonadism and fertility outcomes.
The aim of this study is to assess the impact of clomiphene citrate on serum insulin like growth factor 1 and testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy and/or medical treatment.
In this prospective, open label, single center trial, sixteen male patients were studied. Clomiphene citrate (50 mg/day) was added to previous medical treatment for 3 months and hormonal assessment was performed prior to and during the intervention. Hormones included: growth hormone, insulin like growth factor, total testosterone, follicle stimulating hormone, luteinizing hormone and prostate-specific antigen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate | Experimental | Drug: Clomiphene CitratePatients receiving clomiphene citrate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with active acromegaly on regular use of a stable dose of Octreotide-LAR and/or cabergoline for at least one year,
- Insulin like growth factor 1 above the reference range during the last year of follow-up and
- testosterone levels within or below the third inferior tertile of normality.
Key exclusion criteria (6 listed)
- radiotherapy in the last 10 years, previous venous embolism (including family members),
- previous prostatic cancer or symptomatic benign hypertrophy,
- triglyceride levels above 400 mg/dL,
- renal failure defined by estimative of renal filtration below 30 ml/min,
- liver disease defined by hepatic enzymes 3 times above normal limit,
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 |
|---|---|---|
| Clomiphene CitrateAlso: Clomid; Serophene; InduxClomiphene citrate, 50 mg, orally for three months | Drug | Clomiphene citrate |
Primary outcome
IGF-1 Levels
Time frame: Day 90
The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).
2 secondary outcomes
Testosterone Levels
Time frame: D90
PSA Levels
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acromegaly
RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
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.
Marcello D Bronstein, MD, PhD study chair
Unit of Neuroendocrinology, Discipline of Endocrinology, Department of Internal Medicine Clinical Hospital of the University of São Paulo Medical School, São Paulo, Brazil
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clomiphene Citrate in people with Acromegaly, run by Felipe Henning Gaia Duarte.
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 3 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: finished, as of the sponsor's last update on 7 May 2019. 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?
Yes. Results are posted in the registry (first posted 7 May 2019). 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?
IGF-1 Levels (time frame: Day 90). 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 7 May 2019.