Trial Outcomes & Findings for Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2) (NCT NCT01534351)

Results Overview

The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

Baseline and Month 12

Results posted on

2018-08-29

Participant Flow

Prior to early study discontinuation, 3 sites were initiated and screened a total of 8 participants. Of the 8 participants, one participant was randomized to finasteride 5 mg once daily for 39 days.

Participant milestones

Participant milestones
Measure	Finasteride Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Tamsulosin Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Finasteride and Tamsulosin Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
Overall Study STARTED	1	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Finasteride Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Tamsulosin Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Finasteride and Tamsulosin Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
Overall Study Study Terminated Early	1	0	0

Baseline Characteristics

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Finasteride n=1 Participants Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Tamsulosin Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Finasteride and Tamsulosin Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Month 12

Population: Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.

The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and Month 12

Population: Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.

Prostate volume was assessed by trans-rectal ultrasound (TRUS).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 54 weeks

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.

Outcome measures

Outcome measures
Measure	Finasteride n=1 Participants Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Tamsulosin Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Finasteride and Tamsulosin Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
Number of Participants Who Experienced an Adverse Event	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.

Outcome measures

Outcome measures
Measure	Finasteride n=1 Participants Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Tamsulosin Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.	Finasteride and Tamsulosin Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
Number of Participants Who Discontinued Treatment Due to an Adverse Event	0 Participants	—	—

Adverse Events

Finasteride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tamsulosin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Finasteride and Tamsulosin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER