Clomiphene Citrate for Treatment of Acromegaly

Status Completed

Clinical 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)

Clinical Trial 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

Related Conditions & MeSH terms

Acromegaly

Clinical Trial Details

NCT number	NCT02274311
Study type	Interventional
Source	University of Sao Paulo General Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	January 2011
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06344650` - Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study
Active, not recruiting	`NCT02092129` - Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.	N/A
Completed	`NCT02012127` - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting	`NCT01265121` - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.	N/A
Terminated	`NCT00765323` - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly	Phase 3
Completed	`NCT00531908` - Physiopathology of Sodium Retention in Acromegaly	N/A
Completed	`NCT00500227` - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed	`NCT01278342` - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients	Phase 4
Active, not recruiting	`NCT01809808` - A Prospective Study of Outcome After Therapy for Acromegaly
Completed	`NCT00145405` - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction	Phase 4
Completed	`NCT00210457` - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients	Phase 3
Recruiting	`NCT05401084` - Diet in the Management of Acromegaly	N/A
Recruiting	`NCT00005100` - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly	N/A
Completed	`NCT00521300` - Preoperative Octreotide Treatment of Acromegaly	Phase 4
Completed	`NCT03548415` - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands	Phase 2
Not yet recruiting	`NCT04066569` - Reproducibility and Utility of OGTT in Acromegaly	N/A
Not yet recruiting	`NCT05298891` - Hypoproteic Diet in Acromegaly	N/A
Recruiting	`NCT04520646` - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy	N/A
Not yet recruiting	`NCT04529356` - The TMS Treatment for Postoperative Headache in GH Tumor	N/A
Active, not recruiting	`NCT03252353` - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly	Phase 3