Trial Outcomes & Findings for Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction (NCT NCT04984993)

Last Updated: 2023-09-21

Results Overview

Co-primary objectives: * Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument. * Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4. The IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

116 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2023-09-21

Participant Flow

The first informed consent was on September 14, 2021 and the last study visit was on June 13, 2022.

Of 232 screened patients (males and females enrolled for eligibility assessment), 192 patients and their partners were randomised to treatment. Of the 40 patients and partners that failed screening, 36 did not satisfy inclusion criteria and 2 were excluded for other reasons.

Participant milestones

Participant milestones
Measure	MED3000 MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation	Tadalafil Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets
Overall Study STARTED	96	96
Overall Study Received Treatment	94	94
Overall Study COMPLETED	82	92
Overall Study NOT COMPLETED	14	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MED3000 MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation	Tadalafil Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets
Overall Study Withdrawal by Subject	8	2
Overall Study Lost to Follow-up	2	2
Overall Study Both patients moved to another country	4	0

Baseline Characteristics

Data are presented separately for male participants and female partners.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: MED3000 randomised patients (the only group considered for this outcome). Week 24 values for patients who do not have a Week 24 IIEF-EF value due to early treatment discontinuation adversely related to randomised treatment were imputed as baseline value resulting in zero change from baseline. Week 24 values for patients with early termination discontinuation not adversely related to randomised treatment were imputed via multiple imputation method.

Outcome measures

Outcome measures
Measure	MED3000 n=48 Participants MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24	5.73 Score on a scale Standard Error 1.00

SECONDARY outcome

Timeframe: 24 weeks

Population: MED3000 randomised patients (the only group considered for this outcome)

Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting. Percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 1 indicated a time of 5 (10, 15) minutes or less. Question 1 of the Onset of Action questionnaire: \- After application of the gel/taking medication, when did you begin to notice your erection starting?

Outcome measures

Outcome measures
Measure	MED3000 n=48 Participants MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. 5 minutes	24.01 percentage of uses per patient Standard Deviation 33.43
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. 15 minutes	62.59 percentage of uses per patient Standard Deviation 39.18
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. 10 minutes	47.81 percentage of uses per patient Standard Deviation 36.26

SECONDARY outcome

Timeframe: 24 weeks

Population: MED3000 randomised patients (the only group considered for this outcome)

Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex. Percentage of MED3000 uses per patient that resulted in the patient being able to have penetrative sex within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 2 indicated a time of 5 (10, 15) minutes or less. Question 2 of the Onset of Action questionnaire: \- After application of the gel/taking medication, when were you able to have penetrative sex?

Outcome measures

Outcome measures
Measure	MED3000 n=48 Participants MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. 15 minutes	55.70 percentage of uses per patient Standard Deviation 36.13
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. 10 minutes	31.91 percentage of uses per patient Standard Deviation 29.30
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. 5 minutes	13.72 percentage of uses per patient Standard Deviation 22.33

Adverse Events

MED3000

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Tadalafil

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MED3000 n=47 participants at risk；n=94 participants at risk MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation	Tadalafil n=47 participants at risk；n=94 participants at risk Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets
Infections and infestations Appendicitis	0.00% 0/94 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	1.1% 1/94 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.

Other adverse events

Other adverse events
Measure	MED3000 n=47 participants at risk；n=94 participants at risk MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation	Tadalafil n=47 participants at risk；n=94 participants at risk Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets
Gastrointestinal disorders Nausea (Male)	4.3% 2/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	0.00% 0/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
General disorders Non-cardiac chest pain (Male)	0.00% 0/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	4.3% 2/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Musculoskeletal and connective tissue disorders Back Pain (Male)	0.00% 0/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	4.3% 2/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Nervous system disorders Headache (Male)	4.3% 2/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	19.1% 9/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Nervous system disorders Headache (Female)	6.4% 3/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	0.00% 0/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Gastrointestinal disorders Abdominal distension (Male)	2.1% 1/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	2.1% 1/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Investigations Gamma-glutamyltransferase increased (Male)	2.1% 1/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	2.1% 1/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Musculoskeletal and connective tissue disorders Pain in extremity (Male)	2.1% 1/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.	2.1% 1/47 • 29 Weeks Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.

Additional Information

Andrew Graham, Senior Clinical Project Manager

Futura Medical Development Ltd.

Phone: +44 1483 685682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After completion, the results of the clinical investigation (CI) may be published (first publication shall be referred to as the "Primary Paper"). Results of the CI shall not be published before the primary paper after which PIs may propose publications, including or based on results of the CI, to the Sponsor for review at least 2 months before the planned submission for publication or public disclosure. The Sponsor will provide written approval or reasoned refusal for submission or disclosure.
Publication restrictions are in place

Restriction type: OTHER

Measure	MED3000 n=96 Participants MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation	Tadalafil n=96 Participants Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets	Total n=192 Participants Total of all reporting groups
Age, Continuous Male	44.5 Years n=48 Participants • Data are presented separately for male participants and female partners.	39.0 Years n=48 Participants • Data are presented separately for male participants and female partners.	40.5 Years n=96 Participants • Data are presented separately for male participants and female partners.
Age, Continuous Female	39.5 Years n=48 Participants • Data are presented separately for male participants and female partners.	38.0 Years n=48 Participants • Data are presented separately for male participants and female partners.	39.0 Years n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Male · 22-29	5 Participants n=48 Participants • Data are presented separately for male participants and female partners.	7 Participants n=48 Participants • Data are presented separately for male participants and female partners.	12 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Male · 30-39	16 Participants n=48 Participants • Data are presented separately for male participants and female partners.	18 Participants n=48 Participants • Data are presented separately for male participants and female partners.	34 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Male · 40-49	5 Participants n=48 Participants • Data are presented separately for male participants and female partners.	13 Participants n=48 Participants • Data are presented separately for male participants and female partners.	18 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Male · 50-59	10 Participants n=48 Participants • Data are presented separately for male participants and female partners.	5 Participants n=48 Participants • Data are presented separately for male participants and female partners.	15 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Male · 60-70	12 Participants n=48 Participants • Data are presented separately for male participants and female partners.	5 Participants n=48 Participants • Data are presented separately for male participants and female partners.	17 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Male · <22	0 Participants n=48 Participants • Data are presented separately for male participants and female partners.	0 Participants n=48 Participants • Data are presented separately for male participants and female partners.	0 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Female · 22-29	10 Participants n=48 Participants • Data are presented separately for male participants and female partners.	8 Participants n=48 Participants • Data are presented separately for male participants and female partners.	18 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Female · 30-39	13 Participants n=48 Participants • Data are presented separately for male participants and female partners.	18 Participants n=48 Participants • Data are presented separately for male participants and female partners.	31 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Female · 40-49	3 Participants n=48 Participants • Data are presented separately for male participants and female partners.	11 Participants n=48 Participants • Data are presented separately for male participants and female partners.	14 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Female · 50-59	16 Participants n=48 Participants • Data are presented separately for male participants and female partners.	7 Participants n=48 Participants • Data are presented separately for male participants and female partners.	23 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Female · 60-70	5 Participants n=48 Participants • Data are presented separately for male participants and female partners.	3 Participants n=48 Participants • Data are presented separately for male participants and female partners.	8 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Age, Customized Female · <22	1 Participants n=48 Participants • Data are presented separately for male participants and female partners.	1 Participants n=48 Participants • Data are presented separately for male participants and female partners.	2 Participants n=96 Participants • Data are presented separately for male participants and female partners.
Sex: Female, Male Female	48 Participants n=96 Participants	48 Participants n=96 Participants	96 Participants n=192 Participants
Sex: Female, Male Male	48 Participants n=96 Participants	48 Participants n=96 Participants	96 Participants n=192 Participants
Ethnicity (NIH/OMB) Male · Hispanic or Latino	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=96 Participants • Ethnicity for male \& female participants
Ethnicity (NIH/OMB) Male · Not Hispanic or Latino	48 Participants n=48 Participants • Ethnicity for male \& female participants	48 Participants n=48 Participants • Ethnicity for male \& female participants	96 Participants n=96 Participants • Ethnicity for male \& female participants
Ethnicity (NIH/OMB) Male · Unknown or Not Reported	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=96 Participants • Ethnicity for male \& female participants
Ethnicity (NIH/OMB) Female · Hispanic or Latino	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=96 Participants • Ethnicity for male \& female participants
Ethnicity (NIH/OMB) Female · Not Hispanic or Latino	48 Participants n=48 Participants • Ethnicity for male \& female participants	48 Participants n=48 Participants • Ethnicity for male \& female participants	96 Participants n=96 Participants • Ethnicity for male \& female participants
Ethnicity (NIH/OMB) Female · Unknown or Not Reported	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=48 Participants • Ethnicity for male \& female participants	0 Participants n=96 Participants • Ethnicity for male \& female participants
Region of Enrollment United States	8 Participants n=96 Participants • Data are presented for both male and female participants	10 Participants n=96 Participants • Data are presented for both male and female participants	18 Participants n=192 Participants • Data are presented for both male and female participants
Region of Enrollment Poland	52 Participants n=96 Participants • Data are presented for both male and female participants	56 Participants n=96 Participants • Data are presented for both male and female participants	108 Participants n=192 Participants • Data are presented for both male and female participants
Region of Enrollment Georgia	32 Participants n=96 Participants • Data are presented for both male and female participants	28 Participants n=96 Participants • Data are presented for both male and female participants	60 Participants n=192 Participants • Data are presented for both male and female participants
Region of Enrollment Bulgaria	4 Participants n=96 Participants • Data are presented for both male and female participants	2 Participants n=96 Participants • Data are presented for both male and female participants	6 Participants n=192 Participants • Data are presented for both male and female participants
Height	177.50 cm n=48 Participants • Data are presented for male participants only as not collected in females	180.00 cm n=48 Participants • Data are presented for male participants only as not collected in females	179.00 cm n=96 Participants • Data are presented for male participants only as not collected in females
Weight	85.70 kg n=48 Participants • Data are presented for male participants only as not collected for females	85.15 kg n=48 Participants • Data are presented for male participants only as not collected for females	85.35 kg n=96 Participants • Data are presented for male participants only as not collected for females
Body Mass Index	26.985 kg/m2 n=48 Participants • Data are presented for male participants only as not determined in females	26.759 kg/m2 n=48 Participants • Data are presented for male participants only as not determined in females	26.959 kg/m2 n=96 Participants • Data are presented for male participants only as not determined in females
Baseline Erectile Dysfunction (ED) severity Mild	19 Participants n=48 Participants • Data are presented for male participants only as not relevant for females	19 Participants n=48 Participants • Data are presented for male participants only as not relevant for females	38 Participants n=96 Participants • Data are presented for male participants only as not relevant for females
Baseline Erectile Dysfunction (ED) severity Moderate	17 Participants n=48 Participants • Data are presented for male participants only as not relevant for females	17 Participants n=48 Participants • Data are presented for male participants only as not relevant for females	34 Participants n=96 Participants • Data are presented for male participants only as not relevant for females
Baseline Erectile Dysfunction (ED) severity Severe	12 Participants n=48 Participants • Data are presented for male participants only as not relevant for females	12 Participants n=48 Participants • Data are presented for male participants only as not relevant for females	24 Participants n=96 Participants • Data are presented for male participants only as not relevant for females