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A novel finasteride 0.25% topical solution for androgenetic alopecia: Pharmacokinetics and effects on plasma androgen levels in healthy male volunteers
Abstract and Figures
Objective:
Finasteride, a selective inhibitor of type 2 5-alpha reductase isoenzyme, inhibits the conversion of testosterone to dihydrotestosterone (DHT) and is indicated in the treatment of male androgenetic alopecia. The study objective was to evaluate a newly developed finasteride 0.25% topical solution in comparison to the marketed finasteride 1 mg tablet, with respect to finasteride pharmacokinetics and suppressive effects on plasma DHT.
Methods:
24 healthy men with androgenetic alopecia were randomized in a single center, open-label, parallel-group, exploratory study, and received either multiple scalp applications of the topical solution b.i.d. or oral doses of the reference tablet o.d. for 7 days. Plasma finasteride, testosterone and DHT concentrations were determined.
Results:
After multiple doses, mean (± SD) finasteride Cmax and AUC0-t corresponded to 0.46 ± 0.28 ng/mL and 6.64 ± 7.50 ng/mL x h for the topical solution and to 6.86 ± 1.78 ng/mL and 57.93 ± 29.38 ng/mL x h for the tablet. Plasma DHT was reduced by ~ 68 - 75% with the topical solution and by ~ 62 - 72% with the tablet. No relevant changes occurred for plasma testosterone with either treatment. No clinically significant adverse events occurred.
Conclusions:
A strong and similar inhibition of plasma DHT was found after 1 week of treatment with the topical and tablet finasteride ormulations, albeit finasteride plasma exposure was significantly lower with the topical than with the oral product (p < 0.0001).
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... Furthermore, measurements of serum FIN or DUT concentration are not typical laboratory tests that one can do in order to fit the model parameters to their situation. [16,17] and 5 mg [18][19][20][21]. It should be added that the values reported in the literature are averages with a variability of more than 70% [12]. ...
... Thus, specific percentages (multiplied by the dosage) can be used instead, which will be summarised later at the equations section. [17] and B [16]. The 5 mg data were extracted from the figures of the studies C [18], D [19], E [20], F [21]. [25] with most studies reporting 2-3 h [26,27]. ...
... For example 1 mg FIN every other day is (almost) equivalent to 0.5 mg daily. 32% [12] 19-32% 30-40% 10-15% 8-20% [14] 24% 15% 6% [7] 29% 28% [35] 29% 5% 2% 2% [8] 27% 30% 8% 4% [36] 27% 6% [37] 10% [15] 40% [16] 25-30% [32] 62% [38] 44% ...
Dihydrotestosterone (DHT) is associated with benign prostatic hyperplasia, prostate cancer, and androgenetic alopecia (male pattern hair loss). The enzyme 5α-reductase (5a-R) converts testosterone to DHT. Finasteride and dutasteride are the most commonly prescribed 5a-R inhibitors (blockers), approved for the treatment of prostate and/or hair issues. While the dosages are standardised, some persons have concerns for adverse health effects and experiment with lower or less frequent dosages or combinations of the two drugs. In this paper we model the intake of these drugs, separately or simultaneously, at different dosages and frequencies. The model is a simplified approach of previously published models with simplified pharmacokinetics, but expanding the pharmacodynamics to include both drugs simultaneously. The results are compared with the literature and different drug dosages and combination protocols are discussed.
... Furthermore, measurements of serum FIN or DUT concentration are not typical laboratory tests that one can do in order to fit the model parameters to their situation. [16,17] and 5 mg [18][19][20][21]. It should be added that the values reported in the literature are averages with a variability of more than 70% [12]. ...
... Thus, specific percentages (multiplied by the dosage) can be used instead, which will be summarised later at the equations section. [17] and B [16]. The 5 mg data were extracted from the figures of the studies C [18], D [19], E [20], F [21]. [25] with most studies reporting 2-3 h [26,27]. ...
... For example 1 mg FIN every other day is (almost) equivalent to 0.5 mg daily. 32% [12] 19-32% 30-40% 10-15% 8-20% [14] 24% 15% 6% [7] 29% 28% [35] 29% 5% 2% 2% [8] 27% 30% 8% 4% [36] 27% 6% [37] 10% [15] 40% [16] 25-30% [32] 62% [38] 44% ...
Dihydrotestosterone (DHT) is associated with benign prostatic hyperplasia, prostate cancer, and androgenetic
alopecia (male pattern hair loss). The enzyme 5α-reductase (5a-R) converts testosterone to DHT. Finasteride and
dutasteride are the most commonly prescribed 5a-R inhibitors (blockers), approved for the treatment of prostate
and/or hair issues. While the dosages are standardised, some persons have concerns for adverse health effects and
experiment with lower or less frequent dosages or combinations of the two drugs. In this paper we model the intake
of these drugs, separately or simultaneously, at different dosages and frequencies. The model is a simplified
approach of previously published models with simplified pharmacokinetics, but expanding the pharmacodynamics
to include both drugs simultaneously. The results are compared with the literature and different drug dosages and
combination protocols are discussed.
... While its mechanism of action remains similar to oral FIN, topical application could potentially reduce the risk of systemic side effects. (14) Studies investigating the efficacy of topical FIN have shown promising results in hair growth and maintenance, although direct comparisons with oral FIN require further research. One of the challenges of topical FIN lies in achieving consistent and sufficient drug delivery to hair follicles. ...
... These studies have investigated different aspects of topical FIN, including dosing regimens, application techniques, and treatment durations. (14) Research findings have provided insights into the potential efficacy of topical FIN in promoting hair regrowth and reducing HL. Some studies have reported positive outcomes, including increased hair density and improvements in hair follicle health. ...
Hair loss (HL), scientifically known as alopecia, is a prevalent condition affecting individuals globally. Its multifactorial origins encompass genetics, hormonal fluctuations, stress, aging, medical conditions, and medications. The psychological impact of HL on self-esteem, confidence, and overall quality of life has driven the pursuit of effective treatments to rejuvenate hair growth and appearance. Among these treatments, finasteride (FIN) has been employed to address male pattern HL, the most prevalent form of HL in men. This medication hinders the conversion of testosterone to dihydrotestosterone (DHT), a hormone that contributes to hair follicle shrinkage and cessation of hair production. While oral FIN has been widely explored, it entails undesirable side effects and varying effectiveness. This review delves into the role of FIN topical applications as a novel approach for HL treatment.(International Journal of Biomedicine. 2023;13(4):236-239.) Keywords: hair loss • hair follicle • finasteride • dihydrotestosterone For citation: Hussein RS. The Role of Topical Finasteride in Hair Loss Management: Current Evidence and Future Perspectives.
... Finasteride is also used for benign prostatic hyperplasia (5mg/ day), being suspected that could increase the risk of high-grade prostate cancer. In respect to androgenetic alopecia, finasteride can be administered in the form of tablets, 1mg/ day, or as topical solution applied on the scalp once or twice a day (1)(2)(3). ...
... A 1 mL hydroxypropyl chitosan solution with 0.25% finasteride applied twice daily was compared to a 1 mg oral tablet once daily in a 7-day observational study with 24 men. Even though the topical finasteride resulted in a lower plasma exposure 24 hours after its administration, both formulations produced the maximum effect after multiple doses: a reduction in DHT levels of around 70%, without significant differences [55]. Although no relevant adverse event was identified to be drug-related, the systemic decrease in DHT levels indicates the potential for systemic adverse effects. ...
Androgenic alopecia has a high incidence, affecting 80% of men and 50% of women in their lifetimes. Although not a life-threatening disease, it can be a deep psychological burden to patients and still lacks an effective and safe treatment. Dutasteride is a5-alpha-reductase inhibitor approved to treat benign prostatic hyperplasia that is also commonly prescribed off-label to treat androgenic alopecia. However, oral dutasteride may cause several severe sexual and neurological sideeffects. Therefore, an effective, localized dutasteride treatment that can reduce the effects of systemic uptake is of great interest. Here, we review available therapies to treat androgenic alopecia focusing on topicalformulations developed thus far-including minoxidil, finasteride, and cosmetics-and on dutasteride-loaded nanocarriers targeting hair follicles.
... Finjuve Spray is considered a safer and more convenient way to get the same benefits minimizing these issues. In clinical trials, the Finjuvegroup showed blood concentration levels of only one-hundredth of the oral form after 24 weeks of treatment (Caserini et al., 2014;Todeschini et al., 2022). Furthermore, developing a long-lasting medicine is crucial to improve the effectiveness and convenience of hair loss treatments. ...
Therapeutic antibodies (Abs) have been anticipated as promising alternatives to conventional treatments such as topical minoxidil and oral finasteride for androgenetic alopecia (AGA). Due to the high molecular weight of typical Abs, the half-life of subcutaneous Abs exceeds 2 weeks, allowing an administration intervals of once a month or longer. Direct injection into the areas of hair loss is also feasible, potentially enhancing treatment efficacy while minimizing systemic side effects. However, therapeutic Abs are rarely developed for AGA therapy due to the requirement to be responsiveness to androgens and to exist in the extracellular fluid or cell surface surrounding the hair follicle. In this review, we introduce recent progress of antibody therapeutics in AGA targeting the prolactin receptor, Interleukin-6 receptor, C-X-C motif chemokine ligand 12, and dickkopf 1. As therapeutic Abs for AGA are still in the early stages, targets need further validation and optimization for clinical application.
Current FDA-approved treatments for androgenetic alopecia (AGA) are oral finasteride and topical minoxidil. Topical finasteride offers a potential alternative with similar efficacy and fewer systemic side effects. This study evaluated the effectiveness and safety of combining topical finasteride and minoxidil for male AGA. This 12-week randomized controlled trial divided subjects into two groups which are topical finasteride 0.1%-minoxidil 5% (treatment) and topical minoxidil 5% (control) (NCT05990400, registered 2023-08-04). Hair density, hair diameter, terminal hair rate, and vellus hair rate (assessed using phototrichogram), and the occurrence of side effects (SE) was monitored at four-week intervals. Out of 40 subjects, 2 dropped out in the treatment group. Significant increases in hair density, diameter, and terminal hair rate; and decrease of vellus hair rate were observed at each visit compared to baseline, yet no differences between groups. Systemic SEs included libido reduction (control), mild erectile dysfunction, and chest pain (treatment). Common local SEs (itching, shedding, and dandruff) were similar between groups. One patient (treatment) experienced contact dermatitis. Combining topical finasteride 0.1% with topical minoxidil 5% has similar safety and effectiveness for increasing hair density and diameter in male AGA patients compared to topical minoxidil 5% after 12 weeks of observation.
This study aimed to evaluate the pharmacokinetics (PK), safety, and local tolerability of local finasteride spray (0.25% solution in HPCH, once daily, volume 200 μL) after single and multiple doses in Chinese male volunteers with androgenetic alopecia.
Twelve male patients with androgenetic alopecia received once-daily scalp application of the solution for 7 days. Blood samples were collected at specified time points (on day 1, days 3–6, and day 7 of the trial) and plasma finasteride concentrations were determined by HPLC–MS.
After single-dose administration, the Cmax of finasteride was 15.2 ± 5.54 pg/mL, Tmax was 11.00 (3.00, 20.00) h, AUC0–24h was 263 ± 76.6 h·pg/mL, t1/2 was 35.3 ± 47.7 h, and CL/F was 974 ± 518 L/h. After 7 days of multiple doses, Cmax,ss was 29.7 ± 12.9 pg/mL, Tmax,ss was 8.00 (3.00, 12.00) h, AUCtau,ss was 530 ± 251 h·pg/mL, AUC0–t,ss was 790 ± 464 h·pg/mL, t1/2,ss was 22.6 ± 10.7 h, and CL/Tss was 1080 ± 658 L/h. No clinically significant adverse events occurred during the study.
Compared to single-dose administration, multiple-dose administration of finasteride resulted in a stable half-life, minimal changes in clearance rate, and approximately twofold accumulation in exposure over 7 days. Multiple-dose administration of finasteride spray was well tolerated in Chinese male volunteers with androgenetic alopecia.
Objectives
Androgenic alopecia (AGA) is common among men. Currently, topical minoxidil and oral finasteride are approved by the FDA for the treatment of AGA. Unfortunately, neither of them is completely effective and systemic adverse events have been reported after finasteride administration. Triple Hair Inc. has developed a new topical treatment regimen using a combination of finasteride, latanoprost and minoxidil – TH07. Each of the compounds was effective and safe as a topical treatment in animal models and clinical studies of AGA. The aim of this proof-of-concept study was to evaluate the effectiveness of the TH07 in comparison to the 3 drugs as monotherapy on hair growth in men with AGA.
Methods
Patients with light to moderate AGA were randomized to be treated topically, once daily, for 6 months with TH07, 0.1% finasteride, 0.03% latanoprost, or 5% minoxidil. Data of investigators’ assessment based on pictures, as well as patients’ self-assessment and satisfaction, were collected.
Results
A moderate hair re-growth in the majority of the participant treated with TH07 in comparison to the retreatment with its active components administered as monotherapy was reported by the investigators. Most of the patients treated with TH07 were satisfied with their hair appearance in comparison to the other treatments. No systemic adverse events were reported and the TH07 was well tolerated.
Conclusions
The data of the current study demonstrated that the topical administration of TH07 resulted in an improved efficacy in the treatment of the AGA compared to treatment with each of the ingredients administered separately.
Background. Finasteride 1 mg (Propecia®) is indicated for the treatment of men with androgenetic alopecia (male pattern hair loss, MPHL). However, the long-term (> 2 years) efficacy and safety of finasteride in this population has not been previously reported. Objectives. To assess the efficacy and safety of finasteride in men with MPHL compared to treatment with placebo over five years. Methods. In two 1-year, Phase III trials, 1,553 men with MPHL were randomized to receive finasteride 1 mg/day or placebo, and 1,215 men continued in up to four 1-year, placebo-controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with finasteride led to durable improvements in scalp hair over five years (p ≤ 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. Finasteride was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL, long-term treatment with finasteride 1 mg/day over five years was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment.
The differential stripping technique consists of a tape-stripping phase followed by a cyanoacrylate biopsy. This technique not only allows the quantification of drug retained in the stratum corneum (SC) and in the hair follicles but also differentiates transepidermal from transfollicular penetration. Our study aimed at both validating the differential stripping procedure on hairless rat skin and assessing the role of the hair follicle in the cutaneous penetration of finasteride (FNS) after application of two experimental formulations for 6 or 24 h: P-08-016, a hydroxypropyl chitosan (HPCH)-based formulation and P-10-008, an anhydrous formulation devoid of HPCH. Microscopic and histological evaluation showed that after 15 tape strips both the SC and the viable epidermis were completely removed. A subsequent cyanoacrylate skin surface biopsy led to the removal of the infundibula content. The largest amounts of FNS were found in the epidermis and in the appendages after application of P-08-016, regardless of the time from application. In contrast, smaller and statistically significant amounts of FNS were recovered with P-10-008 6 h after application, compared with that at 24 h. In conclusion, the differential stripping technique allowed determination of the amount of FNS localized in different skin districts, focusing particularly on the follicular contribution. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.
Introduction:
Treatment with 5-alpha reductase inhibitors (5ARI) is commonly utilized for the treatment of benign prostatic hyperplasia (BPH). The true prevalence of sexual side effects with 5ARI treatment is currently unknown.
Areas covered:
The current article reviews the reported adverse effects of 5ARI in regard to erectile function, sexual desire and ejaculation. A PubMed search was performed of all articles from 1990 to present, which reported any sexual side effects with finasteride or dutasteride. Preference was given to more recent and human studies where available.
Expert opinion:
Clinical trials with 5ARI report prevalence rates of de novo erectile dysfunction of 5 - 9%. Decreased circulating dihydrotestosterone (DHT) resulting from 5ARI use is associated with diminished sexual desire and/or orgasm. The presence of adverse sexual effects is associated with decreased self-esteem, quality of life and ability to maintain an intimate relationship. Inhibition of 5ARI additionally influences progesterone and deoxycorticosterone levels and may alter psychological functions, including increased depression, melancholy and loss of general well being. Ejaculatory dysfunction has not been well studied in patients using 5ARI. Patients receiving therapy with 5ARI should be counseled as to potential sexual and psychological adverse effects. Future clinical studies are needed to further investigate the sexual side effects associated with this class of drugs.
Introduction:
Finasteride has been associated with sexual side effects that may persist despite discontinuation of the medication. In a clinical series, 20% of subjects with male pattern hair loss reported persistent sexual dysfunction for ≥6 years, suggesting the possibility that the dysfunction may be permanent. These subjects also reported a wide range of symptoms including changes in cognition, ejaculate quality, and genital sensation. Other medications have been associated with irreversible neurological effects, such as phenothiazines with tardive dyskinesias.
Aim:
To prospectively study whether the persistent sexual side effects associated with finasteride resolve or endure over time.
Methods:
Subjects (N = 54) with persistent sexual side effects associated with finasteride were reassessed after 9-16 months (mean 14 months). All subjects were otherwise healthy young men without any baseline sexual dysfunction, medical conditions, psychiatric conditions, or use of oral prescription medications prior to taking finasteride for male pattern hair loss.
Main outcome measure:
Scores from the Arizona Sexual Experience Scale (ASEX).
Results:
The participation rate was 81%. At reassessment persistent sexual side effects continued to be present in 96% of subjects. According to the ASEX scores, 89% of subjects met the definition of sexual dysfunction. Neither the length of finasteride use nor the duration of the sexual side effects correlated to changes in scores of sexual dysfunction.
Conclusion:
In most men who developed persistent sexual side effects (≥3 months) despite the discontinuation of finasteride, the sexual dysfunction continued for many months or years. Although several rat studies have shown detrimental changes to erectile function caused by 5 alpha reductase inhibitors, the persistent nature of these changes is an area of active research. Prescribers of finasteride and men contemplating its use should be made aware of the potential adverse medication effects.
Many clinical studies reported finasteride-related erectile dysfunction, but to date, few animal experiments have focused on it.
To investigate the effects of oral finasteride on erectile function in a rat model.
Erectile responses and morphological changes.
Adult, male Sprague-Dawley rats were divided into four groups (25/group): (i) control; (ii) castration; (iii) castration with testosterone (T) replacement; and (iv) oral finasteride treatment. Four weeks later, erectile function was measured by the ratio of intracavernosal pressure and mean arterial blood pressure upon electrical stimulation of the cavernous nerve. Serum T and dihydrotestosterone (DHT) and intraprostatic DHT were measured. The weights and histopathological features of the penile corpus cavernosum and prostate were examined.
Serum T and DHT and intraprostatic DHT concentrations, erectile function, and mean weights of the corpus cavernosum and prostate were lowest in group 2. There was no significant difference in the serum T concentration and erectile function between groups 4 and 1. However, the serum and intraprostatic DHT concentrations were significantly lower in group 4 than in group 1 (both P < 0.001). The tissue weights of the corpus cavernosum and prostate were reduced by 25.9% and 92.3% in group 4 compared with group 1 (both P < 0.001). Histopathology revealed a significant atrophy of the prostate in groups 2 and 4. There was a significant decrease in the smooth muscle content in group 2, but not in groups 3 and 4.
In a rat model, finasteride treatment for 4 weeks reduces the weight of the corpus cavernosum but appears not to affect the erectile responses to electrical stimulation of the cavernous nerve. As erection is a complex process involving important signaling in the brain, further studies are necessary to demonstrate the long-term effects of finasteride on both central and peripheral neural pathways of erection.
Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that "persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use."
We sought to characterize the types and duration of persistent sexual side effects in otherwise healthy men who took finasteride for MPHL.
We conducted standardized interviews with 71 otherwise healthy men aged 21-46 years who reported the new onset of sexual side effects associated with the temporal use of finasteride, in which the symptoms persisted for at least 3 months despite the discontinuation of finasteride.
The types and duration of sexual dysfunction and the changes in perceived sexual frequency and sexual dysfunction score between pre- and post-finasteride use.
Subjects reported new-onset persistent sexual dysfunction associated with the use of finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after finasteride use according to the Arizona Sexual Experience Scale (P<0.0001 for both). The mean duration of finasteride use was 28 months and the mean duration of persistent sexual side effects was 40 months from the time of finasteride cessation to the interview date. Study limitations include a post hoc approach, selection bias, recall bias for before finasteride data, and no serum hormone levels.
Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with finasteride.
5α-reductase inhibitors (5α-RIs), finasteride and dutasteride, have been approved for treatment of lower urinary tract symptoms, due to benign prostatic hyperplasia, with marked clinical efficacy. Finasteride is also approved for treatment of hair loss (androgenetic alopecia). Although the adverse side effects of these agents are thought to be minimal, the magnitude of adverse effects on sexual function, gynecomastia, depression, and quality of life remains ill-defined.
The goal of this review is to discuss 5α-RIs therapy, the potential persistent side effects, and the possible mechanisms responsible for these undesirable effects.
We examined data reported in various clinical studies from the available literature concerning the side effects of finasteride and dutasteride.
Data reported in the literature were reviewed and discussed. Results. Prolonged adverse effects on sexual function such as erectile dysfunction and diminished libido are reported by a subset of men, raising the possibility of a causal relationship.
We suggest discussion with patients on the potential sexual side effects of 5α-RIs before commencing therapy. Alternative therapies may be considered in the discussion, especially when treating androgenetic alopecia.
Androgenetic alopecia is the most common form of alopecia in men.
To determine the efficacy and safety of finasteride therapy for patients with androgenetic alopecia.
MEDLINE, EMBASE, CINAHL, Cochrane Registers, and LILACS were searched for randomized controlled trials reported in any language that evaluated the efficacy and safety of finasteride therapy in comparison to treatment with placebo in adults with androgenetic alopecia.
Two reviewers independently evaluated eligibility and collected the data, including assessment of methodological quality (Jadad score). Outcome measures included patient self-assessment, hair count, investigator clinical assessment, global photographic assessment, and adverse effects at short term (≤12 months) and long term (≥24 months). Heterogeneity was explored by testing a priori hypotheses.
Twelve studies fulfilled the eligibility criteria (3927 male patients), 10 of which demonstrated a Jadad score of 3 or more. The proportion of patients reporting an improvement in scalp hair was greater with finasteride therapy than with placebo treatment in the short term (relative risk [RR], 1.81 [95% confidence interval (CI), 1.42-2.32]; I², 64%) and in the long term (RR, 1.71 [95% CI, 1.15-2.53]; I², 16%); both results were considered to have moderate-quality evidence. The number needed to treat for 1 patient to perceive himself as improved was 5.6 (95% CI, 4.6-7.0) in the short term and 3.4 (95% CI, 2.6-5.1) in the long term. Moderate-quality evidence suggested that finasteride therapy increased the mean hair count from baseline in comparison to placebo treatment, expressed as a percentage of the initial count in each individual, at short term (mean difference [MD], 9.42% [95% CI, 7.95%-10.90%]; I², 50%) and at long term (MD, 24.3% [95% CI, 17.92%-30.60%]; I², 0%). Also, the proportion of patients reported as improved by investigator assessment was greater in the short term (RR, 1.80 [95% CI, 1.43-2.26]; number needed to treat, 3.7 [95% CI, 3.2-4.3]; I², 82%) (moderate-quality evidence). Moderate-quality evidence suggested an increase in erectile dysfunction (RR, 2.22 [95% CI, 1.03-4.78]; I², 1%; number needed to harm, 82.1 [95% CI, 56-231]) and a possible increase in the risk of any sexual disturbances (RR, 1.39 [95% CI, 0.99-1.95]; I², 0%). The risk of discontinuing treatment because of sexual adverse effects was similar to that of placebo (RR, 0.88 [95% CI, 0.51-1.49]; I², 5%) (moderate-quality evidence).
Moderate-quality evidence suggests that daily use of oral finasteride increases hair count and improves patient and investigator assessment of hair appearance, while increasing the risk of sexual dysfunction.