Trial · NCT02014584
Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia
NCT02014584, Phase 3, Completed, Stiefel, a GSK Company; results first posted 2017-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia. Trials, record NCT02014584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02014584
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia
- NCT number
- NCT02014584
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- Stiefel, a GSK Company
- Conditions
- Alopecia
- Interventions
- Dutasteride, Placebo
- First posted
- 2013-12-18
- Last updated
- 2018-10-11
- Results first posted
- 2017-03-08
Source ClinicalTrials.gov
Registered outcomes58
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | 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. |
| Primary | Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | 24 weeks | 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. |
| Primary | Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods | 48 weeks | 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. |
| Secondary | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | 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. |
| Secondary | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | 24 weeks | 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. |
| Secondary | Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 48 weeks | 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. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | 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. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | 24 weeks | 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. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 48 weeks | 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. |
| Secondary | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | 24 weeks | 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. |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 registered outcomesOutcomes58
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | Safety Population: all randomized participants who received at least one dose of study treatment. | Participants | NUMBER |
| PRIMARY | Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | 24 weeks | Open-Label Period Population: all participants who entered the open-label period. | Participants | NUMBER |
| PRIMARY | Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods | 48 weeks | Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods. | Participants | NUMBER |
| SECONDARY | Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | Safety Population | Days | MEAN |
| SECONDARY | Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period | 24 weeks | Safety Population | Days | MEAN |
| SECONDARY | Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 48 weeks | Dutasteride DB/OL Combined population | Days | MEAN |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | 24 weeks | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | 24 weeks | Open-Label Period Population | Participants | NUMBER |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods | 48 weeks | Dutasteride DB/OL Combined population | Participants | NUMBER |
| SECONDARY | Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period | 24 weeks | Safety Population | Participants | NUMBER |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 outcomesResults by group596
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | Placebo | 5 | Participants | ||
| Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | Dutasteride 0.5 mg | 9 | Participants | ||
| Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | Placebo (DB)/Dutasteride 0.5 mg (OL) | 3 | Participants | ||
| Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 2 | Participants | ||
| Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 10 | Participants | ||
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Placebo | Altered (decreased) libido n=2,1 | 88.5 | Standard Deviation 103.94 | Days |
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Dutasteride 0.5 mg | Altered (decreased) libido n=2,1 | 44.0 | Standard Deviation NA | Days |
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Placebo | Impotence, n=3, 7 | 68.3 | Standard Deviation 73.35 | Days |
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Dutasteride 0.5 mg | Impotence, n=3, 7 | 78.6 | Standard Deviation 83.09 | Days |
| Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period | Placebo | Ejaculation disorder, n=0, 1 | NA | Standard Deviation NA | Days |
1 to 10 of 596Source ClinicalTrials.gov
See all 596 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period (24 Weeks) | STARTED | Placebo | 59 | |
| Double-Blind Period (24 Weeks) | STARTED | Dutasteride 0.5 mg | 58 | |
| Double-Blind Period (24 Weeks) | STARTED | Placebo (DB)/Dutasteride 0.5 mg (OL) | 0 | |
| Double-Blind Period (24 Weeks) | STARTED | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 0 | |
| Double-Blind Period (24 Weeks) | STARTED | Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL) | 0 | |
| Double-Blind Period (24 Weeks) | STARTED | Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 0 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Placebo | 57 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Dutasteride 0.5 mg | 52 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Placebo (DB)/Dutasteride 0.5 mg (OL) | 0 | |
| Double-Blind Period (24 Weeks) | COMPLETED | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Erectile dysfunction | Reproductive system and breast disorders | Placebo (DB) | 3 | 59 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.5 mg (DB) | 7 | 58 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Placebo (DB)/Dutasteride 0.5 mg (OL) | 1 | 49 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 0 | 48 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 7 | 48 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Placebo (DB) | 2 | 59 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Dutasteride 0.5 mg (DB) | 4 | 58 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Placebo (DB)/Dutasteride 0.5 mg (OL) | 0 | 49 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 4 | 48 | |
| other | Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 8 | 48 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (DB) | ||
| Total, all-cause mortality | Dutasteride 0.5 mg (DB) | ||
| Total, all-cause mortality | Placebo (DB)/Dutasteride 0.5 mg (OL) | ||
| Total, all-cause mortality | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | ||
| Total, all-cause mortality | Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | ||
| Total, other adverse events | Placebo (DB) | 5 | 59 |
| Total, other adverse events | Dutasteride 0.5 mg (DB) | 10 | 58 |
| Total, other adverse events | Placebo (DB)/Dutasteride 0.5 mg (OL) | 1 | 49 |
| Total, other adverse events | Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 4 | 48 |
| Total, other adverse events | Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) | 13 | 48 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dutasteride 0.5 mg vs Placebo: Number of Participants With Treatment-related AEs in the Double-blind Treatment Period | Trial comparisons |
| Dutasteride 0.5 mg vs Placebo: Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period | Trial comparisons |
| Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) vs Placebo (DB)/Dutasteride 0.5 mg (OL): Number of Participants With Treatment-related AEs in the Open-label Treatment Period | Trial comparisons |
| Dutasteride 0.5 mg vs Placebo: Incidence of Premature Discontinuations in the Double-blind Treatment Period | Trial comparisons |
| Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) vs Placebo (DB)/Dutasteride 0.5 mg (OL): Incidence of Premature Discontinuations in the Open-label Treatment Period | Trial comparisons |
| Dutasteride 0.5 mg vs Placebo: Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period | Trial comparisons |
Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) vs Placebo (DB)/Dutasteride 0.5 mg (OL): Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period | Trial comparisons |
| Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL) vs Placebo (DB)/Dutasteride 0.5 mg (OL): Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02014584
GET https://conductscience.org/api/trials/v1/NCT02014584/registered?page=2