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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)

Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

Phase 2
Completed
Conditions
Benign Prostatic Hyperplasia (BPH)
Enlarged Prostate
Interventions
First Posted Date
2008-09-25
Last Posted Date
2012-06-14
Lead Sponsor
Nymox Corporation
Target Recruit Count
85
Registration Number
NCT00759135
Locations
🇺🇸

Nymox Investigational Site, San Antonio, Texas, United States

Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
Dietary Supplement: selenomethionine
Other: placebo
First Posted Date
2008-08-18
Last Posted Date
2023-10-02
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
55
Registration Number
NCT00736645
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

ORAL T-6: Oral Androgens in Man-6

Phase 1
Completed
Conditions
Contraception
Hypogonadism
Interventions
First Posted Date
2008-04-22
Last Posted Date
2011-01-24
Lead Sponsor
University of Washington
Target Recruit Count
16
Registration Number
NCT00663793
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

Fed Study of Finasteride Tablets 5 mg and Proscar® Tablets 5 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-23
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
30
Registration Number
NCT00650377
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

Fasting Study of Finasteride Tablets 5 mg and Proscar Tablets 5 mg

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2008-04-01
Last Posted Date
2024-04-24
Lead Sponsor
Mylan Pharmaceuticals Inc
Target Recruit Count
29
Registration Number
NCT00648791
Locations
🇺🇸

Kendle International Inc., Morgantown, West Virginia, United States

The Use of Finasteride to Reduce Hematuria and Hematospermia Following TRUS Prostate Biopsy

Phase 2
Terminated
Conditions
Hematuria
Hematospermia
Interventions
First Posted Date
2008-01-25
Last Posted Date
2014-01-31
Lead Sponsor
University of British Columbia
Target Recruit Count
29
Registration Number
NCT00600691
Locations
🇨🇦

Royal Jubilee Hospital, Victoria, British Columbia, Canada

🇨🇦

Victoria General Hospital, Victoria, British Columbia, Canada

On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)

Phase 3
Withdrawn
Conditions
Benign Prostatic Hyperplasia
Interventions
Drug: Placebo
First Posted Date
2007-11-28
Last Posted Date
2017-10-30
Lead Sponsor
University of Alberta
Registration Number
NCT00564460
Locations
🇨🇦

Alberta Urology Institute, Edmonton, Alberta, Canada

Topical Finasteride in the Treatment of Idiopathic Hirsutism

Not Applicable
Completed
Conditions
Idiopathic Hirsutism
First Posted Date
2007-11-27
Last Posted Date
2007-11-27
Lead Sponsor
Iran University of Medical Sciences
Target Recruit Count
56
Registration Number
NCT00564252

A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy

Phase 3
Completed
Conditions
Enlarged Prostate
Interventions
Drug: Placebo
First Posted Date
2007-10-11
Last Posted Date
2015-12-09
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
19
Registration Number
NCT00542243
Locations
🇨🇦

University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada

5-Alpha Reductase and Anabolic Effects of Testosterone

Phase 2
Completed
Conditions
Male Hypogonadism
Muscle Atrophy
Sarcopenia
Benign Prostate Hypertrophy
Interventions
First Posted Date
2007-05-21
Last Posted Date
2018-10-11
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
60
Registration Number
NCT00475501
Locations
🇺🇸

North Florida/South Georgia Veterans Health System, Gainesville, Florida, United States

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