Trial Outcomes & Findings for IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE) (NCT NCT03055806)

Last Updated: 2019-10-07

Results Overview

Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

239 participants

Primary outcome timeframe

Last 4 weeks of treatment compared to baseline

Results posted on

2019-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Overall Study STARTED	48	48	71	72
Overall Study COMPLETED	42	41	58	57
Overall Study NOT COMPLETED	6	7	13	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Overall Study Adverse Event	0	0	1	1
Overall Study Lost to Follow-up	0	3	6	7
Overall Study Physician Decision	1	0	0	1
Overall Study Protocol Violation	1	0	0	0
Overall Study Withdrawal of consent to continue drug	1	1	2	0
Overall Study Withdrawal of consent to continue study	2	3	4	6
Overall Study Partner not willing to try intercourse	1	0	0	0

Baseline Characteristics

IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT), Patient Reported Outcomes and Safety in Men With Premature Ejaculation (PE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=48 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=68 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=69 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	Total n=231 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 9.13 • n=5 Participants	41.8 years STANDARD_DEVIATION 9.28 • n=7 Participants	40.1 years STANDARD_DEVIATION 9.78 • n=5 Participants	43.8 years STANDARD_DEVIATION 8.63 • n=4 Participants	41.6 years STANDARD_DEVIATION 9.29 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	48 Participants n=7 Participants	68 Participants n=5 Participants	69 Participants n=4 Participants	231 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants	42 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	43 Participants n=7 Participants	57 Participants n=5 Participants	50 Participants n=4 Participants	189 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	40 Participants n=5 Participants	35 Participants n=7 Participants	58 Participants n=5 Participants	57 Participants n=4 Participants	190 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	27 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment United States	46 participants n=5 Participants	48 participants n=7 Participants	68 participants n=5 Participants	69 participants n=4 Participants	231 participants n=21 Participants

PRIMARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Population: Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period	42.6 Seconds Standard Error 10.9	39.7 Seconds Standard Error 10.6	44.5 Seconds Standard Error 9.0	29.2 Seconds Standard Error 9.1

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline	1.77 Fold change Standard Error 0.11	1.56 Fold change Standard Error 0.11	1.79 Fold change Standard Error 0.09	1.54 Fold change Standard Error 0.09

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline	0.30 Proportion of participants	0.20 Proportion of participants	0.26 Proportion of participants	0.20 Proportion of participants

SECONDARY outcome

Timeframe: Baseline to the end of treatment (approximately 8 weeks)

Population: Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).

7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses \[better (2) or much better (3)\] on this scale.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire Better	0.12 Proportion of participants	0.05 Proportion of participants	0.07 Proportion of participants	0.07 Proportion of participants
Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire Much better	0 Proportion of participants	0.02 Proportion of participants	0.12 Proportion of participants	0 Proportion of participants

SECONDARY outcome

Timeframe: Baseline to the end of treatment (approximately 8 weeks)

Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=44 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=61 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=62 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire.	0.35 Proportion of participants	0.18 Proportion of participants	0.33 Proportion of participants	0.18 Proportion of participants

SECONDARY outcome

Timeframe: Baseline to the end of treatment (approximately 8 weeks)

Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'.

Outcome measures

Outcome measures
Measure	Placebo n=43 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=44 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=61 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=62 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire	0.37 Proportion of participants	0.25 Proportion of participants	0.39 Proportion of participants	0.23 Proportion of participants

SECONDARY outcome

Timeframe: Baseline to the end of treatment (approximately 8 weeks)

Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer).

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Proportion of Patients Achieving Change in Category of ≥2 on Control of Timing of Ejaculation and Achieving Change in Category of ≥1 in Ejaculation-related Personal Distress at End of Treatment	0.13 Proportion of participants	0.11 Proportion of participants	0.25 Proportion of participants	0.08 Proportion of participants

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer scored as 0) to very good (this is the best answer scored as 4).

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Mean Change From Baseline in Score on Control of Ejaculation	0.55 score on a scale Standard Deviation 0.938	0.46 score on a scale Standard Deviation 0.837	0.58 score on a scale Standard Deviation 0.868	0.32 score on a scale Standard Deviation 0.619

SECONDARY outcome

Timeframe: Last 4 weeks of treatment compared to baseline

Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=46 Participants 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=65 Participants 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=64 Participants 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Mean Change From Baseline in Score on Ejaculation-related Personal Distress	0.73 score on a scale Standard Deviation 1.139	0.38 score on a scale Standard Deviation 1.036	0.58 score on a scale Standard Deviation 0.933	0.51 score on a scale Standard Deviation 0.898

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

IX-01 400 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

IX-01 800 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

IX-01 1200 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Ixchelsis Limited

Phone: 44 (0) 1227-832760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor may chose to collaborate on authorship, and sponsor's agent has 60-day review.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo n=46 participants at risk Three placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 400 mg n=48 participants at risk 400 mg dose comprising one 400 mg caplet and two placebo caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 800 mg n=68 participants at risk 800 mg dose comprising two 400 mg caplets and one placebo caplet administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity	IX-01 1200 mg n=69 participants at risk 1200 mg dose comprising three 400 mg caplets administered orally at least 1 hour before or after food and 1-6 hours prior to sexual activity
Nervous system disorders Dizziness	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Nervous system disorders Headache	6.5% 3/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	4.2% 2/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.9% 2/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.9% 2/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Nervous system disorders Hypersomnia	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Nervous system disorders Memory impairment	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Nervous system disorders Parosmia	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Nervous system disorders Poor quality sleep	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Infections and infestations Bronchitis	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Infections and infestations Gastroenteritis	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Infections and infestations Nasopharyngitis	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.9% 2/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Infections and infestations Otitis media	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Infections and infestations Tinea cruris	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Infections and infestations Upper respiratory tract infection	4.3% 2/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Psychiatric disorders Abnormal dreams	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Psychiatric disorders Depressed mood	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Psychiatric disorders Insomnia	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Psychiatric disorders Libido decreased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Psychiatric disorders Libido increased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Blood potassium increased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Blood pressure increased	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Haematocrit increased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Neutrophil count increased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Red blood cell count increased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Red blood cells urine positive	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations Weight decreased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Investigations White blood cell count increased	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Gastrointestinal disorders Abdominal pain	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Gastrointestinal disorders Dry mouth	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Gastrointestinal disorders Dyspepsia	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	2.1% 1/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Gastrointestinal disorders Faeces discoloured	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Injury, poisoning and procedural complications Concussion	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Injury, poisoning and procedural complications Laceration	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Injury, poisoning and procedural complications Skin abrasion	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Injury, poisoning and procedural complications Stress fracture	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.4% 1/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Musculoskeletal and connective tissue disorders Myalgia	2.2% 1/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/46 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/48 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	1.5% 1/68 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).	0.00% 0/69 • Adverse event data were collected from Baseline (Week 0) to the Follow-Up visit (Week 10).