Clomiphene Citrate for Treatment of Acromegaly

Felipe Henning Gaia Duarte

Status and phase

Completed

Phase 2

Conditions

Acromegaly

Treatments

Drug: Clomiphene Citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT02274311

ClomipheneAcro

Details and patient eligibility

About

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)

Full 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.

Enrollment

16 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.