Clomiphene Citrate for Treatment of Acromegaly

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 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, , 

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