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Finasteride

Generic Name
Finasteride
Brand Names
Entadfi, Propecia, Proscar
Drug Type
Small Molecule
Chemical Formula
C23H36N2O2
CAS Number
98319-26-7
Unique Ingredient Identifier
57GNO57U7G
Background

Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker.

Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

Indication

Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. A combination product with tadalafil is also used for the symptomatic treatment of BPH for up to 26 weeks.

Finasteride is also indicated for the treatment of male pattern hair loss (androgenetic alopecia, hereditary alopecia, or common male baldness) in male patients.

Associated Conditions
Androgenetic Alopecia (AGA), Benign Prostatic Hyperplasia (BPH), Idiopathic Hirsutism, Symptomatic benign prostatic hyperplasia (BPH)

High Risk Prostate Cancer Prevention Study

Not Applicable
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-08-04
Last Posted Date
2014-01-01
Lead Sponsor
University of Kansas
Target Recruit Count
18
Registration Number
NCT01174953
Locations
🇺🇸

Veterans Administration Medical Centenr, Kansas City, Missouri, United States

🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

Phase 3
Completed
Conditions
Benign Prostatic Hyperplasia
Enlarged Prostate
Interventions
First Posted Date
2010-06-09
Last Posted Date
2013-02-27
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
696
Registration Number
NCT01139762
Locations
🇹🇷

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Izmir, Turkey

Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-28
Last Posted Date
2010-05-28
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
24
Registration Number
NCT01133457
Locations
🇨🇦

MDS Pharma Services, Cohen street, saint-laurent, montreal (quebec), Canada

Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-28
Last Posted Date
2010-07-12
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
24
Registration Number
NCT01133444
Locations
🇨🇦

MDS Pharma Services, Cohen street, saint-laurent, montreal (quebec), Canada

Association of Polymorphisms in the Androgen Receptor Gene and Finasteride Response in Women With Androgenetic Alopecia

Phase 1
Completed
Conditions
Androgenetic Alopecia
Interventions
First Posted Date
2010-01-20
Last Posted Date
2010-01-20
Lead Sponsor
HairDx, LLC
Target Recruit Count
12
Registration Number
NCT01052870

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions

First Posted Date
2009-03-30
Last Posted Date
2010-08-16
Lead Sponsor
Actavis Inc.
Target Recruit Count
26
Registration Number
NCT00871247
Locations
🇨🇦

SFBC Anapharm, Sainte-Foy, Quebec, Canada

A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions

First Posted Date
2009-03-27
Last Posted Date
2010-08-16
Lead Sponsor
Actavis Inc.
Target Recruit Count
26
Registration Number
NCT00870480
Locations
🇨🇦

SFBC Anapharm, Sainte-Foy, Quebec, Canada

Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy

Phase 1
Completed
Conditions
Retinal Disease
Interventions
First Posted Date
2009-02-05
Last Posted Date
2016-09-26
Lead Sponsor
National Eye Institute (NEI)
Target Recruit Count
5
Registration Number
NCT00837252
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Finasteride 5 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-04
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
32
Registration Number
NCT00835666
Locations
🇺🇸

Novum Pharmaceutical Research Services, Houston, Texas, United States

Finasteride 5 mg Tablets, Non-fasting

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-02-04
Last Posted Date
2024-08-19
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
20
Registration Number
NCT00835796
Locations
🇺🇸

Novum Pharmaceutical Research Services, Houston, Texas, United States

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