Brief Title
Clomiphene Citrate for Treatment of Acromegaly
Official Title
Clomiphene Citrate for Treatment of Acromegaly Not Controlled by Conventional Therapies
Brief 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)
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
IGF-1 Levels
Secondary Outcome
Testosterone Levels
Condition
Acromegaly
Intervention
Clomiphene Citrate
Study Arms / Comparison Groups
Clomiphene citrate
Description: Patients receiving clomiphene citrate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
16
Start Date
January 2011
Completion Date
October 2014
Primary Completion Date
October 2014
Eligibility Criteria
Inclusion Criteria: - 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. Exclusion Criteria: - 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.
Gender
Male
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Marcello D Bronstein, MD, PhD, ,
Administrative Informations
NCT ID
NCT02274311
Organization ID
ClomipheneAcro
Responsible Party
Sponsor-Investigator
Study Sponsor
Felipe Henning Gaia Duarte
Study Sponsor
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
Verification Date
April 2019