Clinical trials
Jump to: Finasteride • Dutasteride
This page summarizes clinical trials of finasteride and dutasteride, focusing on phases II–IV. For details on study design and sponsorship, see papers and documents in the last column of tables. (For background, see an introduction from NIH: What are Clinical Trials and Studies?)
Finasteride was developed by Merck. Dutasteride was developed by GlaxoSmithKline (now GSK). The trials are organized around the following indications and events:
- 1992: Finasteride (5 mg) approved for treatment of benign prostatic hyperplasia (BPH), with brand name Proscar
- 1994–2004: Finasteride (5 mg) studied for the prevention of prostate cancer (PCPT trial)
- 1997: Finasteride (1 mg) approved for treatment of male pattern hair loss (MPHL), with brand name Propecia
- 2001: Dutasteride (0.5 mg) approved for treatment of BPH, with brand name Avodart
- 2003–2010: Dutasteride studied for prevention and management of prostate cancer (REDUCE and REDEEM trials, respectively)
BPH and prostate cancer are treated by urologists, while MPHL is treated by dermatologists. Trials for each indication involved physician-researchers in the relevant specialty as investigators, authors and consultants. Results were often reported in that specialty’s journals.
Avodart (dutasteride 0.5 mg) has been approved for the treatment of male pattern hair loss (androgenetic alopecia) in South Korea and Japan. It is not approved for this indication in the United States, and no approval for treating hair loss has been found in countries regulated by the European Medicines Agency.
For more information about both drugs, see a comparison table, drug labels and a post on the origins of finasteride.
Abbreviations: AGA, androgenetic alopecia; BPH, benign prostatic hyperplasia; MPHL, male pattern hair loss.
Finasteride
In column 2, the number of patients refers to the number enrolled in the study, before randomization.
See also: Research of J. Imperato-McGinley whose work provided the basis for finasteride’s mechanism.
| Condition treated / topic | Purpose & participants | Dates | Papers |
|---|---|---|---|
| BPH | Determine the hormonal effects of MK-906, an orally active 5a-reductase inhibitor, on serum androgens and androgen conjugates 12 Caucasian men, age 50–71; ~8 weeks | ~1987–88 | Rittmaster 1989 |
| Not specified | Effect of finasteride on circulating androgens in men Part 1: 42 men age 19–46; 11 days. Part 2: 30 men age 40–77; 14 days | ~1988 | Gormley 1990 Stoner 1990 (review) |
| BPH | Effects of a range of finasteride doses on androgen levels in men 69 male students, age not specified | ~1988 | Vermeulen 1991 |
| BPH | Finasteride Study Group: Phase II trial Effects of finasteride in patients with BPH Study 1: 86 men age 40–80; 12 weeks + 12-week drug-free Study 2: 104 men age 40–80; 24 weeks | ~1988–89 | Stoner 1992 |
| BPH | Compare effect of finasteride on 1) 5ɑ-reduced C19 and C21 metabolites and 2) plasma T, DHT and LH in male pseudohermaphrodites and men aged 45–75 [note F1] Group 1: ~41 men age 45–75. Group 2: 46 adult male pseudohermaphrodites with inherited 5ɑ-reductase deficiency | 1980s | Imperato-McGinley 1990 |
| BPH | Finasteride Study Group: Phase II extension Determine if previously reported short-term efficacy was maintained with longer-term therapy 67 men age 45–77; 1 year | ~1989–90 | Gormley 1991 |
| BPH | Finasteride Study Group: North American Phase III trial Safety and efficacy of finasteride in men with BPH 896 men age 40–83 with BPH; 12 months with 4-year open-label extension | ~1990–91 | Gormley 1992 Guess 1993 Stoner 1994 Hudson 1999 (extension) |
| BPH | Finasteride Study Group: International Phase III trial Safety, tolerability and efficacy of finasteride 1 mg and 5 mg men with BPH 750 men age 40–80 with BPH; 12 months | ~1990–91 | Finasteride Study Group 1993 Stoner 1994 |
| BPH | Finasteride Study Group Long-term 6-year experience with finasteride for BPH, based on extensions of North American and International Phase III trials | ~1990–1996 | Lowe 2003 |
| BPH | Scandinavian Clinical Study of Finasteride in the Treatment of Benign Prostatic Hyperplasia 182 patients age 40–80 with urinary symptoms; 24 weeks with 12-month open extension | ~1990–1991 | Beisland 1992 |
| BPH | Long-term urodynamic effects of finasteride in BPH: pilot study UK. 69 men; 3 months with open extension | 1992–93 | Kirby 1993 |
| BPH | CUSP: Community Based Study of Proscar Efficacy, tolerability and effect on health-related quality of life in men with BPH At community-based urology clinics; Black and Hispanic patients especially encouraged to participate 2342 men age 45 and older; 1 year | 1990s | Byrnes 1995 |
| BPH | Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group Efficacy and safety of finasteride, terazosin, or both in men with BPH A community study conducted at Veterans Affairs outpatient clinics. Men age 45–80; 1 year | 1992–95 | Lepor 1996 Lepor 1998 |
| BPH | PROSPECT: Proscar Safety Plus Efficacy Canadian Two Year Study Efficacy and safety of 2 years of treatment of moderate BPH Canada 613 men age 45–80; 2 years | 1992–94 | Nickel 1996 |
| BPH | Primary Care Investigator Study Group Efficacy and tolerability of finasteride in a primary care setting 2112 patients age 45 and older; 1 year | 1993–95 | Tenover 1997 |
| BPH | Efficacy and safety of finasteride in men with BPH China 50 men age 50–82; 6 months | ~1994 | Yu 1995 |
| Sexual function | Effect of finasteride (5 mg) on sleep-related erections, potency & libido 20 men (9 taking finasteride), age 41–64; 3 months | ~1994 | Cunningham 1995 |
| BPH | Finasteride Long-Term Efficacy and Safety Study Group Long-term effects of finasteride on symptoms of BPH and incidence of related outcomes including acute urinary retention and need for surgery 3040 men, mean age 64; 4 years | 1990–92 | McConnell 1998 |
| BPH | PROWESS: Proscar Worldwide Efficacy and Safety Study “A large study…to [clarify] issues of finasteride response and prostate size” 3270 men, age 50–75; 2 years | ~1994–97 | Marberger 1998 |
| BPH | MTOPS: Medical Therapy of Prostatic Symptoms Compare effects of doxazosin, finasteride, combination therapy and placebo on progression of BPH 3047 recruited, age 50 and older; mean follow-up 4.5 years | 1993–98 | McConnell 1998 Kaplan 2016 (adverse experiences) |
| BPH | EPICS: Enlarged Prostate International Comparator Study Finasteride vs. dutasteride for BPH Sponsored by GlaxoSmithKline 1630 men, age 50 and older; 1 year plus 2 year open-label phase | 1998–2003 | Nickel 2011 |
| Prostate cancer incidence | PLESS: Proscar Long-term Efficacy and Safety Study Prostate cancer incidence and predictive properties of PSA 3040 men, age 45–78; up to 4 years | 1991–96 | Andriole 1998 Bruskewitz 1999 Roehrborn 1999 Yang 1999 Kaplan 2000 Roehrborn 2000 Wessells 2003 Roehrborn 2004 |
| Prostate cancer prevention | PCPT: Prostate Cancer Prevention Trial Test whether finasteride could reduce the risk of prostate cancer (read more at National Cancer Institute – NIH) Funded by National Cancer Institute. Run by Southwestern Oncology Group (SWOG) 18,882 men, age 55 and older; 10 years | 1994–2004 | Coltman 1999 (update) Higgins 2004 (current status) Lotan 2005 Mellon 2005 Lucia 2007 Moinpour 2007 |
| MPHL | Phase 2 study 047: finasteride 5 mg for treatment of male pattern baldness 227 men, age 18–36; 1 year plus 2-year extension | 1992–94 | Medical Review Part 1, from page 8 in New Drug Application to FDA |
| MPHL | Finasteride Male Pattern Hair Loss Study Group Phase 3 studies 087 (US) & 089 (International): Determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss (MPHL) 1553 men with MPHL, age 18–41; 1 year with four 1-year extensions | 1994–96 | Medical Review in New Drug Application to FDA Kaufman 1998 Finasteride Male Pattern Hair Loss Study Group 2002 Shapiro 2003 Price 2006 Kaufman 2008a Kaufman 2008b |
| MPHL | Phase 3 study 092: Efficacy and safety of finasteride in men with frontal hair loss 326 men, age 18–40 (mean age ~32.5); 1 year with 1-year open extension | ~1994–96 | Leyden 1999 |
| MPHL | Additional studies in Propecia New Drug Application Study 081: Dose Range Study 094: Safety Study 065: Scalp DHT and Sebum Study 031: Scalp DHT Study 012: Semen Production #1 Study 056: Semen Production #2 | 1990s | Medical Review Part 1, from p. 8 Roberts 1999 (Dose Range) Drake 1999 (Scalp & Serum DHT) (No publications found for: 094, Safety; 012: Semen Production #1; 056: Semen Production #2) |
| Semen parameters | Potential effect and reversibility of effect of finasteride on semen parameters, prostate volume and serum PSA 181 men, age 19–41; 48 weeks with 60-week off-drug reversibility period | Unknown | Overstreet 1999 |
| MPHL | Effect of finasteride on phases of hair growth cycle 10 centers in Europe; 2 centers in US 212 men, age 18–40; 48 weeks | Late 1990s | Van Neste 2000 |
| MPHL | Changes in hair weight and hair count 66 men, age 22–40; 48 weeks with 48-week extension | Unknown | Price 2002 |
| MPHL | Efficacy of finasteride with placebo in the treatment of male pattern hair loss in nine pairs of male identical twins 9 pairs of identical twins; 1 year | Unknown | Stough 2002 |
| MPHL | Finasteride Male Pattern Hair Loss Study Group Efficacy and tolerability in men aged 41 to 60 years with male pattern hair loss 424 men, age 41–60; 2 years | Unknown | Whiting 2003 |
| MPHL | Finasteride in the treatment of Japanese men with male pattern hair loss Sponsored by Banyu Pharmaceutical Co., Japan [note F2] Japan 414 men, age 20–40; 48 weeks | 2001–02 | Kawashima 2004 |
| MPHL | Evaluate whether finasteride improves scalp hair and growth in areas surrounding the transplant, and safety and tolerability in men undergoing hair transplant 79 men, age 20–45; 1 year | 2000–03 | Leavitt 2005 |
| Semen parameters & serum hormones | Effect of finasteride and dutasteride, relative to placebo, on semen parameters and serum levels of reproductive hormones Sponsored by GlaxoSmithKline 99 men, age 18–55; 1 year, with follow-up for 24 weeks after end of treatment | 1999–2001 | Amory 2007 |
| MPHL | Three related trials of finasteride in Japanese men with androgenetic alopecia. “The same patients were included in the three investigations, but each study period was completely different.” –Yanagisawa 2022 1. Efficacy and safety of finasteride 1 mg in 3177 Japanese men with androgenetic alopecia (2006–09) 2. Efficacy of finasteride in 801 Japanese Men with androgenetic alopecia (2000–08) 3. Long-Term (10-Year) efficacy of finasteride in 523 Japanese men with androgenetic alopecia (2005–09) | 2000–09 | Sato 2011 Yoshitake 2015 Yanagisawa 2019 Yanagisawa 2022: summary of all trials |
| Acne in women | Compare efficacy, tolerability and safety of montelukast versus finasteride in the treatment of moderate acne in women. 65 female subjects with moderate acne vulgaris, age 15–38; 12 weeks. | 2018–2020 | Rokni 2021 |
| MPHL | 1. Efficacy and safety of topical finasteride compared to placebo 2. Degree of systemic exposure to finasteride Sponsored by Polichem and Almirall 458 enrolled men, age 18–40; 24 weeks. Conducted at 45 sites in Europe. | 2022 | Piraccini 2022 |
Notes:
F1. C19 and C21 metabolites are “neuroactive and neuroprotective steroids, androgens and androgen precursors” (Stárka et al., 2006).
F2. Merck had a controlling stake in Banyu from the 1980s and took full ownership of the company in 2003.
Dutasteride
In column 2, the number of patients refers to the number enrolled in the study, before randomization.
| Condition treated / topic | Purpose & participants | Dates | Papers |
|---|---|---|---|
| BPH | ARIA3001 (US), ARIA3002 (US) & ARIA3003 (19 countries) Dutasteride for BPH 4235 men, age 50 and older; 2 years | 1997–2002 | Roehrborn 2002 Roehrborn 2004 (ARIA3001, 3002) |
| BPH | ARIA108898: Chinese Dutasteride Phase III Trial Dutasteride in Chinese adults with BPH 253 men, age 50 and older; 6 months + 12-month extension | 2007-2009 | Na 2012 |
| BPH | EPICS: Enlarged Prostate International Comparator Study Finasteride vs. dutasteride for BPH Non-US locations 1630 men, age 50 and older; 1 year plus 2 year open-label phase | 1998–2003 | Nickel 2011 |
| BPH | CombAT: Combination of Avodart and Tamsulosin study Effectiveness of dutasteride-tamsulosin combination therapy vs. dutasteride or tamsulosin in reducing risk of urinary retention, BPH-related surgery and BPH clinical progression 4844 men, age 50 and older with moderate-to-severe LUTS due to BPH; 4 years | 2003–2009 | Roehrborn 2010 Montorsi 2011 See additional papers in note D1 |
| BPH | Dutasteride in Japanese men with BPH 378 men, age 50 and older; 1 year with follow-up assessments for 16 weeks | 2000s | Tsukamoto 2009 |
| Prostate cancer prevention | REDUCE: Reduction by Dutasteride of Prostate Cancer Events Effect of dutasteride on the risk of prostate cancer 6729 men, age 60–75; 4 years | 2003–2009 | Musquera 2008 Andriole 2010 |
| Prostate cancer management | REDEEM: Reduction by Dutasteride of Clinical Progression Events in Expectant Management Evaluate whether dutasteride decreases time to prostate cancer progression 302 men, age 48–82; 302 men recruited; 3 years | 2007–2010 | Fleshner 2007 Fleshner 2012 |
| MPHL | ARIA2004: Dutasteride versus finasteride for hair loss by Dutasteride Alopecia Research Team Phase II dose-ranging study 416 men, age 21–45; 24 weeks | 2004 | Olsen 2006 |
| Semen parameters & serum hormones | Effect of finasteride and dutasteride, relative to placebo, on semen parameters and serum levels of reproductive hormones 99 men, age 18–55; 1 year, with follow-up for 24 weeks after end of treatment | 2000s | Amory 2007 |
| MPHL | Dutasteride in men with male pattern hair loss – Phase III Korea 153 men, age 18–49; 6-month treatment with 4-month follow-up | 2000s | Eun 2010 |
| MPHL | Different doses of dutasteride & finasteride in male subjects with androgenetic alopecia 917 men, age 20–50; 24 weeks | 2010–2012 | Gubelin Harcha 2014 |
| MPHL | Dutasteride for hair loss in identical twins 17 pairs of identical twins, age 18–50; 1 year | 2000s | Stough 2007 |
| MPHL | Sexual function in men taking dutasteride for AGA 117 men, age 23–50; 24 weeks + 24 weeks open-label extension | 2014–2016 | Tsai 2018 |
| BPH | PARTEM: Prostatic artery embolisation versus medical treatment in patients with benign prostatic hyperplasia Compare BPH symptoms after prostatic artery embolisation vs. combination therapy with dutasteride and tamsulosin hydrochloride. | 2023 | Sapoval 2023 |
Note
D1. Additional papers related to CombAT trial: Roehrborn 2008, Barkin 2009, Becher 2009, Chung 2009, Haillot 2011, Roehrborn 2011a, Roehrborn 2011b, Roehrborn 2012, Oelke 2014, Roehrborn 2014