Dutasteride

Number of Participants With an Adverse Event

To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.

The number of adverse events in Japanese subjects with BPH treated with dutasteride capsules

Change in Hemoglobin Levels (Hemoglobin Drop)

Occurrence of adverse event after dutasteride administration

International Prostate Symptoms Score IPSS

Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.

change in serum PSA

Breath Alcohol

Change in American Urologic Association Sympton Score

insulin sensitivity

Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV

Change in 5AR enzyme activity as measured by the DHT/testosterone ratio and levels of 3a-androstanediol glucuronide as a function of time after a single loading dose of dutasteride.

Urodynamic parameters (Qmax, Voided volume, and PVR) and AUASS

Change in Extent of Cancer

Cost of treating prostate-related events

Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach

Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months

Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression

Acute Urinary Retention (AUR) relapse rate during the 24 week treatment period

Heavy Drinking Days Per Week

Time to Disease Progression

Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs

Effects of Testosterone Gel Alone or in Combination With Oral Dutasteride on Prostate Volume in Hypogonadal Men With Benign Prostatic Hyperplasia.

Laboratory parameters: including serum testosterone, DHT level and PSA

Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).

Change Number of Standard Drinks Per Week.

Post-void Residual (PVR) Volume

Relative change in PSA(Prostate-specific antigen)expression per cell at 3 months

the effect of dutasteride on dysuria, voiding and LUTS

Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW)

PSA reduction

Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)

Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.

Change in Total International Prostate Symptom Score (IPSS) from baseline to Week 48

Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months

Efficacy of short-term dutasteride in improving prostate cancer detection

Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52

AUA score will be used to assess severity of urinary symptoms. All patients will be contacted weekly by telephone for 12 weeks then monthly postoperatively to get their AUA score. A total of 21 AUA scores postoperatively.

Total number of hair Changes

Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline.

Percent Change From Baseline in the Prostate Volume at Month 6

rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN

Change From Baseline Hair Growth Assessed by Macrophotographic Technique (Hair Count) in the Vertex at 6 Months.

Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)

Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period

Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF)

bone metabolism

Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index

Change in Heavy Drinking Days Per Week for Dutasteride vs. Placebo Groups

Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis)

To assess whether repeat oral once daily dosing of dutasteride 0.5mg increases the length of the off treatment interval in men receiving intermittent androgen ablation therapy for localized prostate cancer

NIH chronic prostatitis symptom index in study population

Prostate-specific Antigen (PSA)

Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)

Incidence of NMIBC recurrences in patients treated with dutasteride

Total prostate volume

Muscle Strength Change From Baseline

PSA Response

Pathologic Complete Response Rate

Safety and Tolerability

Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine

Number of Participants With Androgen Receptor (AR) Related Mutations

Prostate Tissue DHT

Time to disease progression

Overall Response Rate (ORR)

Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.

Elevations in serum testosterone

To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume.

Intratesticular Testosterone (IT-T) Level

Dutasteride can suppress the secretion of LH and FSH after four weeks of administration.

Lapatinib Maximum Tolerated Dose (MTD) [Phase I]

1. To investigate the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets in the fed and fasted states.

Uroflowmetry result

Growth Hormone concentration after injections

Pharmacokinetic (PK) profile of second generation dutasteride when co-administered with tamsulosin HCL relative to the commercial combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg in the fed state to investigate bioequivalence

Pharmacokinetic profile for second generation dutasteride when co-administered with tamsulosin HCL relative to the currently available commercial combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg in the fed state to investigate bioequivalence

Relative bioavailability of tamsulosin from FDC products (0.5 mg dutasteride /0.2 mg tamsulosin HCl) containing a size 3-oblong dutasteride soft gel capsule and tamsulosin pellets having a range of tamsulosin release rates produced by different mixtures

Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin

AUClast and Cmax of dutasteride and tadalafil

Area Under Curve (AUC) of tadalafil

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product

Cmax

Bioavailability

Rating Scale for Premenstrual Tension (PMTS); Daily symptom rating form (DRF); Visual Analogue Symptom (VAS) self-rating form.

Area Under the Curve(AUC) of Dutasteride

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) of dutasteride test product and reference product

Bioavailability of tamsulosin in 2 FDC formulations (Tamsulosin 0.2 mg and Dutasteride 0.5 mg) relative to co-administration of AVODART capsules with Harnal-D tablets or Harnal capsules in male subjects of Asian ancestry in the fed state

Area under the curve in time plot (AUCt)

To evaluate the pharmacokinetics of dutasteride and tamsulosin when dosed alone and in combination

Occurrence of Dose Limiting Toxicity