Trial Outcomes & Findings for Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia (NCT NCT02014584)

Results Overview

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

117 participants

Primary outcome timeframe

24 weeks

Results posted on

2018-10-11

Participant Flow

The study consisted of a Screening Visit, a 4-week Placebo Run-in Period, a 24-week Double-Blind (DB) Treatment Period, followed by a 24-week Open-Label (OL) Active Treatment Period, and a 4-week post-treatment Follow-Up Visit.

Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.	Placebo (DB)/Dutasteride 0.5 mg (OL) During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.	Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.	Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL) Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.	Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study drug administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
Double-Blind Period (24 Weeks) STARTED	59	58	0	0	0	0
Double-Blind Period (24 Weeks) COMPLETED	57	52	0	0	0	0
Double-Blind Period (24 Weeks) NOT COMPLETED	2	6	0	0	0	0
Open-Label Period (24 Weeks) STARTED	0	0	49	48	0	0
Open-Label Period (24 Weeks) COMPLETED	0	0	44	47	0	0
Open-Label Period (24 Weeks) NOT COMPLETED	0	0	5	1	0	0
Target Follow-up (F/U) Period (24 Weeks) STARTED	0	0	0	0	3	2
Target Follow-up (F/U) Period (24 Weeks) COMPLETED	0	0	0	0	2	2
Target Follow-up (F/U) Period (24 Weeks) NOT COMPLETED	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.	Placebo (DB)/Dutasteride 0.5 mg (OL) During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.	Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.	Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL) Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
Double-Blind Period (24 Weeks) Protocol Violation	0	1	0	0	0
Double-Blind Period (24 Weeks) Withdrawal by Subject	2	5	0	0	0
Open-Label Period (24 Weeks) Lost to Follow-up	0	0	2	0	0
Open-Label Period (24 Weeks) Withdrawal by Subject	0	0	3	1	0
Target Follow-up (F/U) Period (24 Weeks) Withdrawal by Subject	0	0	0	0	1

Baseline Characteristics

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.	Total n=117 Participants Total of all reporting groups
Age, Continuous	39.0 Years STANDARD_DEVIATION 6.77 • n=5 Participants	39.1 Years STANDARD_DEVIATION 6.65 • n=7 Participants	39.0 Years STANDARD_DEVIATION 6.68 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	49 Participants n=5 Participants	48 Participants n=7 Participants	97 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Southeast Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Safety Population: all randomized participants who received at least one dose of study treatment.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period	5 Participants	9 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Open-Label Period Population: all participants who entered the open-label period.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period	3 Participants	2 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods	10 Participants	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period Altered (decreased) libido n=2,1	88.5 Days Standard Deviation 103.94	44.0 Days Standard Deviation NA The standard deviation was not calculated as only 1 participant was analyzed.
Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period Impotence, n=3, 7	68.3 Days Standard Deviation 73.35	78.6 Days Standard Deviation 83.09
Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period Ejaculation disorder, n=0, 1	NA Days Standard Deviation NA The mean and standard deviation was not calculated as no participants were analyzed.	63.0 Days Standard Deviation NA The standard deviation was not calculated as only 1 participant was analyzed.

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period Altered (decreased) libido n=2,1	77.5 Days Standard Deviation 71.42	135.0 Days Standard Deviation NA The standard deviation was not calculated as only 1 participant was analyzed.
Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period Impotence, n=1, 1	181.0 Days Standard Deviation NA The mean and standard deviation was not calculated as only 1 participant was analyzed.	176.0 Days Standard Deviation NA The standard deviation was not calculated as only 1 participant was analyzed.
Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period Ejaculation disorder, n=0, 0	NA Days Standard Deviation NA The mean and standard deviation was not calculated as no participants were analyzed.	NA Days Standard Deviation NA The mean and standard deviation was not calculated as no participants were analyzed.

SECONDARY outcome

Timeframe: 48 weeks

Population: Dutasteride DB/OL Combined population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods Altered (decreased) libido n=1	135.0 Days Standard Deviation NA The standard deviation was not calculated as only 1 participant was analyzed.	—
Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods Impotence, n=8	90.8 Days Standard Deviation 84.28	—
Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods Ejaculation disorder, n=1	63.0 Days Standard Deviation NA The standard deviation was not calculated as only 1 participant was analyzed.	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Open-Label Period Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Dutasteride DB/OL Combined population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods	0 Participants	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period Any AE	18 Participants	19 Participants
Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period Any SAE	1 Participants	1 Participants
Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period PSRAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Open-Label Period Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period Any AE	13 Participants	15 Participants
Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period Any SAE	1 Participants	0 Participants
Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period PSRAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Dutasteride DB/OL Combined population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods Any AE	25 Participants	—
Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods Any SAE	1 Participants	—
Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods PSRAE	0 Participants	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Treatment-related AEs in the Double-blind Treatment Period	5 Participants	11 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Open-Label Period Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Treatment-related AEs in the Open-label Treatment Period	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Dutasteride DB/OL Combined population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods	11 Participants	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Altered (decreased libido)	2 Participants	1 Participants
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Impotence	3 Participants	7 Participants
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Ejaculation disorders	0 Participants	1 Participants
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Breast disorder	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Prostate cancer	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Cardiovascular adverse event	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Double-blind Treatment Period Infrequent adverse events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Open-Label Period Population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Altered (decreased libido)	2 Participants	1 Participants
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Impotence	1 Participants	1 Participants
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Ejaculation disorders	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Breast disorder	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Prostate cancer	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Cardiovascular adverse event	0 Participants	0 Participants
Number of Participants With AEs of Special Interest in the Open-label Treatment Period Infrequent adverse events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Dutasteride DB/OL Combined population

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.

Outcome measures

Outcome measures
Measure	Placebo n=48 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Altered (decreased libido)	1 Participants	—
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Impotence	8 Participants	—
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Ejaculation disorders	1 Participants	—
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Breast disorder	0 Participants	—
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Prostate cancer	0 Participants	—
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Cardiovascular adverse event	0 Participants	—
Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods Infrequent adverse events	2 Participants	—

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Wish to be dead	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Non-specific suicidal thoughts	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Without intent	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period With intent but no plan	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period With plan and intent	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Prep acts/behavior	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Aborted attempt	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Interrupted attempt	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Actual attempt	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period Non-suicidal self injury behavior	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Safety Population

Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Wish to be dead	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Non-specific suicidal thoughts	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Without intent	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period With intent but no plan	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period With plan and intent	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Prep acts/behavior	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Aborted attempt	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Interrupted attempt	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Actual attempt	0 Participants	0 Participants
Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period Non-suicidal self injury behavior	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Safety Population

The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period SBP Week 12, n=59, 53	0.9 millimeter of mercury (mmHg) Standard Deviation 9.71	-0.1 millimeter of mercury (mmHg) Standard Deviation 10.46
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period SBP Week 24, n=57, 52	-1.0 millimeter of mercury (mmHg) Standard Deviation 13.27	-2.0 millimeter of mercury (mmHg) Standard Deviation 14.08
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period DBP Week 12, n=59, 53	2.1 millimeter of mercury (mmHg) Standard Deviation 7.99	1.6 millimeter of mercury (mmHg) Standard Deviation 9.23
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period DBP Week 24, n=57, 52	-0.2 millimeter of mercury (mmHg) Standard Deviation 9.78	-1.5 millimeter of mercury (mmHg) Standard Deviation 9.73

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Open-Label Period Population

Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period SBP Week 12, n=46, 48	-0.9 mmHg Standard Deviation 10.02	0.1 mmHg Standard Deviation 12.76
Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period SBP Week 24, n=44, 47	-0.7 mmHg Standard Deviation 11.30	0.4 mmHg Standard Deviation 12.90
Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period DBP Week 12, n=46, 48	-0.8 mmHg Standard Deviation 8.87	-0.6 mmHg Standard Deviation 9.00
Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period DBP Week 24, n=44, 47	-1.4 mmHg Standard Deviation 8.26	0.9 mmHg Standard Deviation 11.23

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Safety Population

The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in Heart Rate in the Double-blind Treatment Period Week 12, n=59, 53	0.3 Beats per Minute Standard Deviation 8.19	-0.6 Beats per Minute Standard Deviation 11.39
Change From Baseline in Heart Rate in the Double-blind Treatment Period Week 24, n=57, 52	0.6 Beats per Minute Standard Deviation 9.21	-0.7 Beats per Minute Standard Deviation 11.20

SECONDARY outcome

Timeframe: Baseline, Week 12 and Week 24

Population: Open-Label Period Population

Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in Heart Rate in the Open-label Treatment Period Week 12, n=46, 48	-1.5 Beats per Minute Standard Deviation 10.86	1.1 Beats per Minute Standard Deviation 13.15
Change From Baseline in Heart Rate in the Open-label Treatment Period Week 24, n=44, 47	-0.3 Beats per Minute Standard Deviation 10.83	1.2 Beats per Minute Standard Deviation 11.26

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: Safety Population

The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: \<80, upper: \>165) and diastolic blood pressure: (lower: \<40, upper: \>105).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Baseline SBP <80 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Baseline SBP >165 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Baseline DBP <40 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Baseline DBP >105 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Post Baseline SBP <80 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Post Baseline SBP >165 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Post Baseline DBP <40 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period Post Baseline DBP >105 mmHg	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: Open-Label Period Population

The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: \<80, upper: \>165) and diastolic blood pressure: (lower: \<40, upper: \>105).

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Baseline SBP <80 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Baseline SBP >165 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Baseline DBP <40 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Baseline DBP >105 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Post Baseline SBP <80 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Post Baseline SBP >165 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Post Baseline DBP <40 mmHg	0 Participants	0 Participants
Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period Post Baseline DBP >105 mmHg	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: Safety Population

The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: \<40, upper: \>100).

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period Baseline <40	0 Participants	0 Participants
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period Baseline >100	1 Participants	1 Participants
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period Post- Baseline <40	0 Participants	0 Participants
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period Post- Baseline >100	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: Open-Label Period Population

Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: \<40, upper: \>100).

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period Baseline <40	0 Participants	0 Participants
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period Baseline >100	1 Participants	1 Participants
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period Post- Baseline <40	0 Participants	0 Participants
Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period Post- Baseline >100	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: Safety Population

Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures

SECONDARY outcome

Timeframe: Baseline and up to Week 24

Population: Open-Label Period Population

Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).

Outcome measures
Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, sexual life, Much Better	2 Participants	1 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, sexual life, A Little Better	1 Participants	2 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, sexual life, No change	37 Participants	39 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, sexual life, A Little Worse	4 Participants	4 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, sexual life, Much worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, sexual life, Very Much Worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, Very Much Better	1 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, Much Better	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, A Little Better	1 Participants	4 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, No change	42 Participants	39 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, A Little Worse	5 Participants	5 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, Much worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Erection ability, Very Much Worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, Sexual life, Very Much Better	1 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, sexual life, Much Better	0 Participants	1 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, sexual life, A Little Better	2 Participants	2 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, sexual life, No change	40 Participants	39 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, sexual life, A Little Worse	6 Participants	6 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, sexual life, Much worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL Baseline, sexual life, Very Much Worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, Very Much Better	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, Much Better	2 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, A Little Better	1 Participants	4 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, No change	35 Participants	37 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, A Little Worse	6 Participants	5 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, Much worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Erection ability, Very Much Worse	0 Participants	0 Participants
Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period OL week 24, Sexual life, Very Much Better	0 Participants	0 Participants

Adverse Events

Placebo (DB)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Dutasteride 0.5 mg (DB)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo (DB)/Dutasteride 0.5 mg (OL)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (DB) n=59 participants at risk	Dutasteride 0.5 mg (DB) n=58 participants at risk	Placebo (DB)/Dutasteride 0.5 mg (OL) n=49 participants at risk	Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) n=48 participants at risk	Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) n=48 participants at risk
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/59 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	1.7% 1/58 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/49 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	2.1% 1/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.7% 1/59 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/58 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	2.0% 1/49 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.

Other adverse events

Other adverse events
Measure	Placebo (DB) n=59 participants at risk	Dutasteride 0.5 mg (DB) n=58 participants at risk	Placebo (DB)/Dutasteride 0.5 mg (OL) n=49 participants at risk	Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) n=48 participants at risk	Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) n=48 participants at risk
Reproductive system and breast disorders Erectile dysfunction	5.1% 3/59 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	12.1% 7/58 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	2.0% 1/49 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	14.6% 7/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	3.4% 2/59 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	6.9% 4/58 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	0.00% 0/49 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	8.3% 4/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.	16.7% 8/48 • Serious adverse events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of study medication until follow-up (up to 54 weeks). On-treatment SAEs and non-serious AEs are reported for Safety Population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=59 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=58 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Platelet Count DB Week 24, n=54, 47	2.2 Giga per Liter (GI/L) Standard Deviation 37.79	9.6 Giga per Liter (GI/L) Standard Deviation 24.01
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Platelet Count Final Value, n=55, 48	2.3 Giga per Liter (GI/L) Standard Deviation 37.45	9.0 Giga per Liter (GI/L) Standard Deviation 23.93
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period WBC DB Week 24, n=55, 51	0.1 Giga per Liter (GI/L) Standard Deviation 1.39	0.1 Giga per Liter (GI/L) Standard Deviation 1.32
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period WBC Final Value, n=56, 52	0.1 Giga per Liter (GI/L) Standard Deviation 1.35	0.1 Giga per Liter (GI/L) Standard Deviation 1.16
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Basophils DB Week 24, n=50, 46	-0.0 Giga per Liter (GI/L) Standard Deviation 0.03	-0.0 Giga per Liter (GI/L) Standard Deviation 0.03
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Basophils Final Value, n=51, 47	-0.0 Giga per Liter (GI/L) Standard Deviation 0.03	-0.0 Giga per Liter (GI/L) Standard Deviation 0.03
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Eosinophils DB Week 24, n=50, 46	-0.0 Giga per Liter (GI/L) Standard Deviation 0.15	-0.0 Giga per Liter (GI/L) Standard Deviation 0.11
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Eosinophils Final Value, n=51, 47	-0.0 Giga per Liter (GI/L) Standard Deviation 0.15	-0.0 Giga per Liter (GI/L) Standard Deviation 0.13
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Lymphocytes DB Week 24, n=50, 46	0.0 Giga per Liter (GI/L) Standard Deviation 0.76	-0.1 Giga per Liter (GI/L) Standard Deviation 0.59
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Lymphocytes Final Value, n=51, 47	0.1 Giga per Liter (GI/L) Standard Deviation 0.75	-0.0 Giga per Liter (GI/L) Standard Deviation 0.59
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Monocytes DB Week 24, n=50, 46	0.0 Giga per Liter (GI/L) Standard Deviation 0.16	-0.0 Giga per Liter (GI/L) Standard Deviation 0.13
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Monocytes Final Value, n=51, 47	0.0 Giga per Liter (GI/L) Standard Deviation 0.16	-0.0 Giga per Liter (GI/L) Standard Deviation 0.13
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Segmented Neutrophils DB Week 24, n=50, 46	0.1 Giga per Liter (GI/L) Standard Deviation 1.27	0.2 Giga per Liter (GI/L) Standard Deviation 1.31
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Segmented Neutrophils Final Value, n=51, 47	0.1 Giga per Liter (GI/L) Standard Deviation 1.26	0.2 Giga per Liter (GI/L) Standard Deviation 1.14
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Total Neutrophils DB Week 24, n=50, 46	0.1 Giga per Liter (GI/L) Standard Deviation 1.27	0.2 Giga per Liter (GI/L) Standard Deviation 1.31
Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period Total Neutrophils Final Value, n=51, 47	0.1 Giga per Liter (GI/L) Standard Deviation 1.26	0.2 Giga per Liter (GI/L) Standard Deviation 1.14

Measure	Placebo n=49 Participants Participants received placebo administered orally once daily for 24 weeks.	Dutasteride 0.5 mg n=48 Participants Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Platelet Count OL Week 24, n=42, 45	2.1 Giga per Liter (GI/L) Standard Deviation 30.41	-2.5 Giga per Liter (GI/L) Standard Deviation 19.83
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Platelet Count Final Value, n=42, 45	2.1 Giga per Liter (GI/L) Standard Deviation 30.41	-3.4 Giga per Liter (GI/L) Standard Deviation 20.33
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period WBC OL Week 24, n=42, 47	0.2 Giga per Liter (GI/L) Standard Deviation 1.23	0.2 Giga per Liter (GI/L) Standard Deviation 1.71
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period WBC Final Value, n=42, 47	0.1 Giga per Liter (GI/L) Standard Deviation 1.25	0.1 Giga per Liter (GI/L) Standard Deviation 1.68
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Basophils OL Week 24, n=39, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.02	0.0 Giga per Liter (GI/L) Standard Deviation 0.02
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Basophils Final Value, n=40, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.02	0.0 Giga per Liter (GI/L) Standard Deviation 0.02
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Eosinophils OL Week 24, n=39, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.17	0.0 Giga per Liter (GI/L) Standard Deviation 0.14
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Eosinophils Final Value, n=40, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.17	0.0 Giga per Liter (GI/L) Standard Deviation 0.14
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Lymphocytes OL Week 24, n=39, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.47	0.1 Giga per Liter (GI/L) Standard Deviation 0.50
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Lymphocytes Final Value, n=40, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.46	0.1 Giga per Liter (GI/L) Standard Deviation 0.50
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Monocytes OL Week 24, n=39, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.12	-0.0 Giga per Liter (GI/L) Standard Deviation 0.12
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Monocytes Final Value, n=40, 44	-0.0 Giga per Liter (GI/L) Standard Deviation 0.13	-0.0 Giga per Liter (GI/L) Standard Deviation 0.12
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Segmented Neutrophils OL Week 24, n=39, 44	0.2 Giga per Liter (GI/L) Standard Deviation 1.19	0.0 Giga per Liter (GI/L) Standard Deviation 1.72
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Segmented Neutrophils Final Value, n=40, 44	0.2 Giga per Liter (GI/L) Standard Deviation 1.20	0.0 Giga per Liter (GI/L) Standard Deviation 1.72
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Total Neutrophils OL Week 24, n=39, 44	0.2 Giga per Liter (GI/L) Standard Deviation 1.19	0.0 Giga per Liter (GI/L) Standard Deviation 1.72
Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period Total Neutrophils Final Value, n=40, 44	0.2 Giga per Liter (GI/L) Standard Deviation 1.20	0.0 Giga per Liter (GI/L) Standard Deviation 1.72