Erectile DysfunctionPhase 2NCT04969666
A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile Dysfunction
A Phase 2 study testing IPED2015 in people with Erectile Dysfunction, run by Initiator Pharma.
Trial summary
This is a Phase II, randomised, double-blind, parallel-group, placebo-controlled study to investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male subjects with ED. Up to 120 subjects are planned to be enrolled into 3 groups. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- IPED2015
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2021to 30 Nov 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Otherwise healthy male subjects with ED as determined from an IIEF-5 score of <16, with a body mass index of 18 to 35 kg/m2 (inclusive), of any ethnic origin.
- Subject must have had at least one intent to have sexual intercourse during the last 3 months prior to Screening.
Who cannot join
- Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this Protocol.
- Clinically significant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening or Day -7 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder).
- Clinically significant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during the Screening visit may be repeated to confirm eligibility or judged to be clinically irrelevant for otherwise healthy subjects with ED.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Repeat Single Oral Dose Study of IPED2015 or Placebo in Otherwise Healthy Male Subjects With Erectile Dysfunction
This is a Phase II, randomised, double-blind, parallel-group, placebo-controlled study to investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male subjects with ED.
Up to 120 subjects are planned to be enrolled into 3 groups. Group 1 is planned to consist of 60 subjects, Group 2 is planned to consist of 36 subjects and Group 3 is planned to consist of 24 subjects. Groups 1, 2 and 3 will be conducted in parallel. Each subject will be dosed on four occasions. There will be three study treatments of dose 1 of IPED2015, dose 2 of IPED2015 or matched placebo. In each group, subjects will be randomised evenly to each of the three study treatments and will receive the same treatment on each visit.
Read the detailed description
The primary objective of this study is to investigate the effects of repeat single oral doses of IPED2015 on male subjects with erectile dysfunction (ED) on ability to develop and maintain an erection.
- Conditions
- Erectile Dysfunction
- Being tested
- IPED2015, Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPED2015Drug
Active treatment
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| IPED2015_dose 1 | Experimental | Active treatment Receives: Drug: IPED2015 |
| IPED2015_dose 2 | Experimental | Active treatment Receives: Drug: IPED2015 |
| Placebo | Placebo comparator | Placebo treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF-15) scale
Erectile Dysfunction assessment
Measured: 4 weeks
Secondary outcomes (3)
Rigiscan (diagnosis and assessment of male sexual impotence)
Device to assess erectile dysfunction
Measured: 4 weeks
Semen analysis (check of quality of semen)
Analysis of tissue
Measured: 4 weeks
Incidence of Treatment-Emergent Adverse Events
Assessment of patients health
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start4 Aug 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Initiator Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Westhead, MD, Principal investigator, MAC UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969666
- Sponsor's protocol ID
- IPED2015CS02
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Repeat Single Oral Dose Study of IPED2015 or Placebo in Otherwise Healthy Male Subjects With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04969666
- Acronym / sponsor ID
- IPED2015CS02
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Initiator PharmaIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, randomised, double-blind, parallel-group, placebo-controlled study to investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male subjects with ED.
Up to 120 subjects are planned to be enrolled into 3 groups. Group 1 is planned to consist of 60 subjects, Group 2 is planned to consist of 36 subjects and Group 3 is planned to consist of 24 subjects. Groups 1, 2 and 3 will be conducted in parallel. Each subject will be dosed on four occasions. There will be three study treatments of dose 1 of IPED2015, dose 2 of IPED2015 or matched placebo. In each group, subjects will be randomised evenly to each of the three study treatments and will receive the same treatment on each visit.
Detailed description
The primary objective of this study is to investigate the effects of repeat single oral doses of IPED2015 on male subjects with erectile dysfunction (ED) on ability to develop and maintain an erection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPED2015_dose 1 | Experimental | Drug: IPED2015Active treatment |
| IPED2015_dose 2 | Experimental | Drug: IPED2015Active treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Otherwise healthy male subjects with ED as determined from an IIEF-5 score of <16, with a body mass index of 18 to 35 kg/m2 (inclusive), of any ethnic origin.
- Subject must have had at least one intent to have sexual intercourse during the last 3 months prior to Screening.
Key exclusion criteria (3 listed)
- Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this Protocol.
- Clinically significant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening or Day -7 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder).
- Clinically significant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during the Screening visit may be repeated to confirm eligibility or judged to be clinically irrelevant for otherwise healthy subjects with ED.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPED2015Active treatment | Drug | IPED2015_dose 1, IPED2015_dose 2 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
International Index of Erectile Function (IIEF-15) scale
Time frame: 4 weeks
Erectile Dysfunction assessment
3 secondary outcomes
Rigiscan (diagnosis and assessment of male sexual impotence)
Time frame: 4 weeks
Semen analysis (check of quality of semen)
Time frame: 4 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Westhead, MD principal investigator
MAC UK
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPED2015 in people with Erectile Dysfunction, run by Initiator Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael Thomsen (23276134, mt@initiatorpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (IIEF-15) scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.