NCT01294592 (CONDUCT) is a Phase 4 clinical trial of Dutasteride plus tamsulosin in Prostatic Hyperplasia, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01294592?

NCT01294592 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01294592?

Interventions in NCT01294592: Dutasteride plus tamsulosin, tamsulosin.

What condition does NCT01294592 study?

NCT01294592 studies Prostatic Hyperplasia.

Is NCT01294592 still recruiting?

NCT01294592 is currently completed. Last updated 20 August 2018.

Are results published for NCT01294592?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-08-20 · How we verify

NCT01294592: CONDUCT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement

Completed Phase 4 Results posted Last updated 20 August 2018

What this trial tests

Phase 4 trial testing Dutasteride plus tamsulosin in Prostatic Hyperplasia in 742 participants. Completed in 17 October 2013.

Timeline

22 December 2010

Primary endpoint
17 October 2013

17 October 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	742
Start date	22 December 2010
Primary completion	17 October 2013
Estimated completion	17 October 2013
Sites	80 locations across France, Italy, Netherlands, Greece, United Kingdom, Germany, Romania, Spain

Drugs / interventions tested

Dutasteride plus tamsulosin — full drug profile →
tamsulosin (tamsulosin) — full drug profile →

Conditions studied

Prostatic Hyperplasia — all drugs for Prostatic Hyperplasia →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

50 and older, male only, with Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum o

Month 1, n=358, 367

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-3.2	± 0.21
Watchful Waiting All: Escalated Yes and No	-0.9	± 0.20

Month 3, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-4.5	± 0.22
Watchful Waiting All: Escalated Yes and No	-2.4	± 0.22

Month 6, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-4.6	± 0.23
Watchful Waiting All: Escalated Yes and No	-3.2	± 0.22

Month 9, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-5.1	± 0.22
Watchful Waiting All: Escalated Yes and No	-3.6	± 0.22

Month 12, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-5.2	± 0.23
Watchful Waiting All: Escalated Yes and No	-3.6	± 0.23

Month 15, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-5.2	± 0.25
Watchful Waiting All: Escalated Yes and No	-3.6	± 0.24

Month 18, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-5.1	± 0.25
Watchful Waiting All: Escalated Yes and No	-3.3	± 0.25

Month 21, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-5.5	± 0.25
Watchful Waiting All: Escalated Yes and No	-3.6	± 0.24

Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Secondary · Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: \>=1 point through \>=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: \>0 percent, \>=10 percent, \>=20 percent, \>=25 percent, \>=30 percent, \>=40 percent, and \>=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: \>=2 points, \>=3 points, and percent change \>=25. The 7 items in the IPSS questionnaire q

Month 1, >=2 points, n=358, 367

Group	Value	95% CI
Dutasteride Plus Tamsulosin	225
Watchful Waiting All: Escalated Yes and No	149

Month 1, >=3 points, n=358, 367

Group	Value	95% CI
Dutasteride Plus Tamsulosin	182
Watchful Waiting All: Escalated Yes and No	90

Month 1, >=25 percent, n=358, 367

Group	Value	95% CI
Dutasteride Plus Tamsulosin	161
Watchful Waiting All: Escalated Yes and No	76

Month 3, >=2 points, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	277
Watchful Waiting All: Escalated Yes and No	221

Month 3, >=3 points, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	233
Watchful Waiting All: Escalated Yes and No	172

Month 3, >=25 percent, n= 359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	218
Watchful Waiting All: Escalated Yes and No	150

Month 6, >=2 points, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	277
Watchful Waiting All: Escalated Yes and No	250

Month 6, >=3 points, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	245
Watchful Waiting All: Escalated Yes and No	208

Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Secondary · Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on

Month 1, n=357, 366

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.3	± 0.11
Watchful Waiting All: Escalated Yes and No	-0.4	± 0.11

Month 3, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.8	± 0.11
Watchful Waiting All: Escalated Yes and No	-1.0	± 0.11

Month 6, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.9	± 0.11
Watchful Waiting All: Escalated Yes and No	-1.3	± 0.11

Month 9, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-2.1	± 0.11
Watchful Waiting All: Escalated Yes and No	-1.5	± 0.11

Month 12, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-2.1	± 0.12
Watchful Waiting All: Escalated Yes and No	-1.5	± 0.12

Month 15, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-2.2	± 0.12
Watchful Waiting All: Escalated Yes and No	-1.5	± 0.12

Month 18, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-2.2	± 0.12
Watchful Waiting All: Escalated Yes and No	-1.4	± 0.12

Month 21, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-2.4	± 0.12
Watchful Waiting All: Escalated Yes and No	-1.6	± 0.12

Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Secondary · Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

Each participant was asked the following question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". This response was rated from 0 ("delighted") to 6 ("terrible"). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted m

Month 1, n=358, 367

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-0.8	± 0.06
Watchful Waiting All: Escalated Yes and No	-0.3	± 0.05

Month 3, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.1	± 0.06
Watchful Waiting All: Escalated Yes and No	-0.7	± 0.06

Month 6, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.2	± 0.06
Watchful Waiting All: Escalated Yes and No	-0.9	± 0.06

Month 9, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.3	± 0.06
Watchful Waiting All: Escalated Yes and No	-1.0	± 0.06

Month 12, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.3	± 0.06
Watchful Waiting All: Escalated Yes and No	-1.1	± 0.06

Month 15, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.4	± 0.06
Watchful Waiting All: Escalated Yes and No	-1.1	± 0.06

Month 18, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.4	± 0.06
Watchful Waiting All: Escalated Yes and No	-1.1	± 0.06

Month 21, n=359, 368

Group	Value	95% CI
Dutasteride Plus Tamsulosin	-1.5	± 0.06
Watchful Waiting All: Escalated Yes and No	-1.1	± 0.06

Number of Events of Clinical Progression (CP) of BPH Secondary · Up to 2 years

The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS \>=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal ins

Year 1, n=369, 373

Group	Value	95% CI
Dutasteride Plus Tamsulosin	48
Watchful Waiting All: Escalated Yes and No	94

Year 2, n=276, 251

Group	Value	95% CI
Dutasteride Plus Tamsulosin	17
Watchful Waiting All: Escalated Yes and No	14

Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH Secondary · Up to Month 24

CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS \>=3 points from Baseline \[Visit 2\]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of

Participants with CP of BPH, n=369, 373

Group	Value	95% CI
Dutasteride Plus Tamsulosin	65
Watchful Waiting All: Escalated Yes and No	108

BPH symptom progression, n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	59
Watchful Waiting All: Escalated Yes and No	97

BPH-related AUR, n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	2
Watchful Waiting All: Escalated Yes and No	4

BPH-related incontinence, n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	4
Watchful Waiting All: Escalated Yes and No	3

Recurrent BPH-related UTI, n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	0
Watchful Waiting All: Escalated Yes and No	4

BPH-related renal insufficiency, n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	0
Watchful Waiting All: Escalated Yes and No	0

Tied for first component, n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	0
Watchful Waiting All: Escalated Yes and No	0

Multiple components (2 components), n=65, 108

Group	Value	95% CI
Dutasteride Plus Tamsulosin	4
Watchful Waiting All: Escalated Yes and No	9

Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries Secondary · Up to Month 24

BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate \[TURP\], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.

Participants with any BPH-related surgery

Group	Value	95% CI
Dutasteride Plus Tamsulosin	6
Watchful Waiting All: Escalated Yes and No	3

Participants with cystoscopy

Group	Value	95% CI
Dutasteride Plus Tamsulosin	5
Watchful Waiting All: Escalated Yes and No	1

Participants with TURP

Group	Value	95% CI
Dutasteride Plus Tamsulosin	2
Watchful Waiting All: Escalated Yes and No	1

Participants with prostatectomy

Group	Value	95% CI
Dutasteride Plus Tamsulosin	0
Watchful Waiting All: Escalated Yes and No	1

Participants with 2 surgeries

Group	Value	95% CI
Dutasteride Plus Tamsulosin	1
Watchful Waiting All: Escalated Yes and No	0

Participants with >=3 surgeries

Group	Value	95% CI
Dutasteride Plus Tamsulosin	0
Watchful Waiting All: Escalated Yes and No	0

Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Secondary · Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: "Overall, how satisfied are you with the treatment and its effect on your urinary problems?" There were seven possible responses, including: "very satisfied," "satisfied," "somewhat satisfied," neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied." Response categories were created by grouping together "very satisfied," "satisfied," and "somewhat satisfied" responses in

Baseline, Any Satisfaction, n=315, 328

Group	Value	95% CI
Dutasteride Plus Tamsulosin	119
Watchful Waiting All: Escalated Yes and No	122

Baseline, Neutral/Any Dissatisfaction, n=315, 328

Group	Value	95% CI
Dutasteride Plus Tamsulosin	196
Watchful Waiting All: Escalated Yes and No	206

Month 1, Any Satisfaction, n=358, 349

Group	Value	95% CI
Dutasteride Plus Tamsulosin	272
Watchful Waiting All: Escalated Yes and No	209

Month 1, Neutral/Any Dissatisfaction, n=358, 349

Group	Value	95% CI
Dutasteride Plus Tamsulosin	86
Watchful Waiting All: Escalated Yes and No	140

Month 3, Any Satisfaction, n= 359, 359

Group	Value	95% CI
Dutasteride Plus Tamsulosin	300
Watchful Waiting All: Escalated Yes and No	265

Month 3, Neutral/Any Dissatisfaction, n=359, 359

Group	Value	95% CI
Dutasteride Plus Tamsulosin	59
Watchful Waiting All: Escalated Yes and No	94

Month 6, Any Satisfaction, n=359, 361

Group	Value	95% CI
Dutasteride Plus Tamsulosin	301
Watchful Waiting All: Escalated Yes and No	285

Month 6, Neutral /Any Dissatisfaction, n=359, 361

Group	Value	95% CI
Dutasteride Plus Tamsulosin	58
Watchful Waiting All: Escalated Yes and No	76

Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach Secondary · Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24

The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: "Would you ask your doctor for the treatment you received in this study?" There were three possible responses, including: "Yes," "No," and "Not sure." Response categories included "Yes" and "No or Not Sure," created by grouping together "No" and "Not sure." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for

Baseline, Yes, n=315, 328

Group	Value	95% CI
Dutasteride Plus Tamsulosin	109
Watchful Waiting All: Escalated Yes and No	103

Baseline, No or Not Sure, n=315, 328

Group	Value	95% CI
Dutasteride Plus Tamsulosin	206
Watchful Waiting All: Escalated Yes and No	225

Month 1, Yes, n=358, 347

Group	Value	95% CI
Dutasteride Plus Tamsulosin	224
Watchful Waiting All: Escalated Yes and No	166

Month 1, No or Not Sure, n=358, 347

Group	Value	95% CI
Dutasteride Plus Tamsulosin	134
Watchful Waiting All: Escalated Yes and No	181

Month 3, Yes, n=359, 357

Group	Value	95% CI
Dutasteride Plus Tamsulosin	232
Watchful Waiting All: Escalated Yes and No	207

Month 3, No or Not Sure, n=359, 357

Group	Value	95% CI
Dutasteride Plus Tamsulosin	127
Watchful Waiting All: Escalated Yes and No	150

Month 6, Yes, n=359, 360

Group	Value	95% CI
Dutasteride Plus Tamsulosin	232
Watchful Waiting All: Escalated Yes and No	227

Month 6, No or Not Sure, n=359, 360

Group	Value	95% CI
Dutasteride Plus Tamsulosin	127
Watchful Waiting All: Escalated Yes and No	133

Exposure to Study Drug Secondary · Up to 2 years

Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.

Group	Value	95% CI
Dutasteride Plus Tamsulosin	639.8	± 215.49
Watchful Waiting Escalated=Yes	566.3	± 195.13

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization Secondary · Up to 2 years

A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scienti

Any AE

Group	Value	95% CI
Dutasteride Plus Tamsulosin	190
Watchful Waiting All: Escalated Yes and No	119
Watchful Waiting Escalated=Yes	95

Any SAE

Group	Value	95% CI
Dutasteride Plus Tamsulosin	38
Watchful Waiting All: Escalated Yes and No	25
Watchful Waiting Escalated=Yes	19

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs) and non-serious adverse events (AEs) starting post-randomization (including events with an onset on or after the randomization date or with a missing onset date) were collected (up to 2 years).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dutasteride Plus Tamsulosin

Serious: 38/369 (10%)

Deaths: —

Watchful Waiting All: Escalated Yes and No

Serious: 25/373 (7%)

Deaths: —

Watchful Waiting Escalated=Yes

Serious: 19/229 (8%)

Deaths: —

Serious adverse events (78 terms)

Reaction	System	Dutasteride Plus Tamsulosin	Watchful Waiting All: Esca…	Watchful Waiting Escalated…
Atrial fibrillation	Cardiac disorders	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—
Cellulitis	Infections and infestations	—	—	—
Diverticulitis	Infections and infestations	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—
Presyncope	Nervous system disorders	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Prostatitis	Reproductive system and breast disorders	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Aortic valve stenosis	Cardiac disorders	—	—	—
Atrioventricular block	Cardiac disorders	—	—	—
Cardiomyopathy	Cardiac disorders	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Tachyarrhythmia	Cardiac disorders	—	—	—
Heart valve incompetence	Cardiac disorders	—	—	—
Erysipelas	Infections and infestations	—	—	—
Pilonidal cyst	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Infective exacerbation of chronic obstructive airways	Infections and infestations	—	—	—
Infected cyst	Infections and infestations	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Dutasteride Plus Tamsulosin	Watchful Waiting All: Esca…	Watchful Waiting Escalated…
Erectile dysfunction	Reproductive system and breast disorders	—	—	—
Retrograde ejaculation	Reproductive system and breast disorders	—	—	—

Most-reported serious reactions: Atrial fibrillation, Respiratory tract infection, Cellulitis, Diverticulitis, Inguinal hernia, Presyncope, Colon cancer, Prostate cancer.

Data from ClinicalTrials.gov NCT01294592 adverse events section.

Sponsor's own description

Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH). Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire. After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (Duodart(®) ) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both provided with lifestyle advice, in the management of treatment-naïve men wit
Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, et al · · 2015 · cited 52× · PMID 25565364 · DOI 10.1111/bju.13033
Can we use baseline characteristics to assess which men with moderately symptomatic benign prostatic hyperplasia at risk of progression will benefit from treatment? A post hoc analysis of data from the 2-year CONDUCT study.
Roehrborn CG, Oyarzabal Perez I, Roos EP, Calomfirescu N, et al · · 2017 · cited 8× · PMID 27334136 · DOI 10.1007/s00345-016-1884-5

Verify or expand the search:

Other trials of Dutasteride plus tamsulosin

Trials testing the same drug.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01294592 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01294592.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01294592: CONDUCT

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (78 terms)

Sponsor's own description

Publications & conference data

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