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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene citrate | Experimental | Patients receiving clomiphene citrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene Citrate | Drug | Clomiphene citrate, 50 mg, orally for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | D90 |
| PSA Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcello D Bronstein, MD, PhD | Unit of Neuroendocrinology, Discipline of Endocrinology, Department of Internal Medicine Clinical Hospital of the University of São Paulo Medical School, São Paulo, Brazil | Study Chair |
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Patients should be on stable medical treatment for at least 6 months prior entering the study. Patients submitted to radiotherapy in the last 10 years were not eligible.
Acromegalic patients with uncontrolled hormonal levels despite current medical treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Clomiphene Citrate | Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months 16 patients were enrolled |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Three Months of Clomiphene Treatment |
| |||||||||||||
| Three Months of Clomiphene Wash-out |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clomiphene Citrate | Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months Patients with active acromegaly, defined by high IGF-1 levels, on regular use of a stable dose of Octreotide-LAR and/or Cabergoline for at least 1 year; IGF-1 above the reference range during the last year of follow-up; and T levels within or below the third inferior tertile of normality. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | ng/mL | Day 90 |
|
|
Adverse event data were collected at D90 (3 months after the begging of the study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clomiphene Citrate | Patients receiving clomiphene citrate Clomiphene Citrate: Clomiphene citrate, 50 mg, orally for three months No adverse events were reported |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Felipe Henning Gaia Duarte | Hospital das Clinicas da Faculdade de Medicina da USP | +5511987550990 | drfelipegaia@outlook.com |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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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).
| Day 90 |
|
| years |
|
| Sex: Female, Male | Only male patients were recruited | Count of Participants | Participants |
|
|
|
| Secondary | 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). | 10 acromegalic patients were assessed, the other 6 patients did not have testosterone levels assessed. | Posted | Median | Standard Deviation | ng/dL | D90 |
|
|
|
| Secondary | 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). | Posted | Median | Standard Deviation | ng/mL | Day 90 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |