Repeat Single Dose Study of IPED2015 or Placebo in Healthy ED Patients
Research type
Research Study
Full 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
IRAS ID
298560
Contact name
Neel Bhatt
Contact email
Sponsor organisation
Initiator Pharma
Eudract number
2021-001669-19
Duration of Study in the UK
1 years, 7 months, 2 days
Research summary
Research Summary
This is a Phase II, randomised, double-blind, parallel-group, placebo (dummy pill) controlled study to investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male subjects between the ages of 18 and 59 with erectile dysfunction (ED).
Erectile dysfunction (ED) is defined as the inability to obtain an erection sufficient for sexual intercourse and affects an increasing number of men. Erectile dysfunction patients have decreased quality-of-life (QoL) caused by various psychosocial reasons such as low self-esteem, depression, sadness, anger, frustration, anxiety and relationship problems. Dopamine is involved in a variety of physiological functions, including sexual behaviour. IPED2015 is a powerful inhibitor of Dopamine transporters and in studies was found to increase dopamine in the synapses (nerve cell signal transmitters) and induce erection in male rats. IPED2015 represents a novel treatment of ED in patients who have failed to respond to other treatments.
Up to 120 participants are planned to be enrolled into 3 groups. Group 1 is planned to consist of 60 participants, Group 2 is planned to consist of 36 participants and Group 3 is planned to consist of 24 participants. Groups 1, 2 and 3 will be conducted in parallel. In this study the self-applied RigiScan Plus Monitor will be used to measure and record penile rigidity over several hours in participants in Group 2 only.
Each participant in the three groups will be dosed on four occasions. There will be three potential study treatments of 5 mg IPED2015, 10 mg IPED2015 or matched placebo (dummy pill). In each group, participants will be randomised evenly to each of the three study treatments and will receive the same treatment on each visit.
The study duration for each participant is expected to be eight weeks and the study will be run at 7 clinical research sites within the UK.
Summary of results
The study was organised and funded by Initiator Pharma (the 'Sponsor') and was conducted by MAC Clinical Research at 7 study sites across the United Kingdom from August 2021 to July 2023.
Why was this study conducted?
The purpose of this study was to test a drug called IPED2015 (the 'study drug') that is being developed for treating erectile dysfunction (ED).
Erectile dysfunction is the term used to describe when a man is unable to develop or sustain an erection, which can lead to difficulties in having sexual intercourse. The most common drugs currently available to treat ED, such as Viagra, work by relaxing the blood vessels in the penis so more blood can be entrapped in the penis to produce an erection. Although these drugs are effective in treating the condition in some men, for around 1 in 3 men, they do not work.
The study drug works differently to current treatments by interacting with the effects of dopamine to help stimulate an erection. Dopamine is a neurotransmitter, which is a chemical messenger responsible for sending messages or signals between brain and nerve cells. The study drug is being developed to treat ED in men for whom current treatments either do not work or are poorly tolerated.
The main aims of this study were:
* To assess the effects of repeat single doses of the study drug on the participant's ability to develop and maintain an erection.
* To assess the safety and tolerability of single doses of the study drug.
* To assess the effect of the study drug on the body using a visual sexual stimulation test.
* To assess the effects of the study drug on sperm count and motility.
* To assess the relationship between how the body absorbs and removes the study drug, and the efficacy (how well the study drug works) and safety of the study drug.
Who took part in the study?
A total of 141 participants with ED were randomly divided into 3 groups and 120 participants completed the study; 11 participants left it before they received a dose of the study drug and another 10 participants left it before the study was completed.
Each participant who completed the study was administered one of the following, once a week for 4 weeks:
* A low dose of IPED2015
* A high dose of IPED2015
* Placebo (a substance that looks like the study drug but does not contain the active ingredient)
What were the overall results of the study?
When participants who were administered the lower dose of IPED2015 were asked the question "since the last visit, when you attempted intercourse, how often were you able to penetrate your partner?", there was an increase in this score that was statistically significant after taking the study drug. Additionally, in these participants there was also an increase in score after taking the study drug when asked the question "since the last visit, during sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner?".
Throughout the study, participants who took the lower dose of IPED2015 generally reported an improvement when they were asked questions about their sexual function and erections, and many of these improvements were statistically significant. On the other hand, participants who took the higher dose of IPED2015 or placebo did not generally see much improvement in their erectile function.
The study demonstrated promising results related to ED, supporting a new treatment model for this patient population.
Some participants in this study experienced side effects (unwanted medical issues that may or may not be related to the study drug), but no serious side effects or safety observations of concern were reported. Mild headache, dizziness and nausea were the most frequently reported side effects in this study.
How has this study helped patients and researchers?
This study was conducted on male participants aged 18 to 59 years with ED who were otherwise healthy. The results from this study are limited to the particular people studied and cannot be assumed true for everybody. Not all participants in the study had the same results.
This research helps future patients and families by helping us understand more about the medicine being studied. Findings from this study will be used in other studies to compare this drug with other treatments for ED.
Where can I find more information about this study?
To learn more about this study, visit https://scanmail.trustwave.com/?c=261&d=gNfD5qwpKHbyghD0YA-CD54hEiXxdkscoWUu3E-9JA&u=https%3a%2f%2fclick%2epstmrk%2eit%2f3t%2fwww%2eclinicaltrials%2egov%2e%2fNBTI%2fVC21AQ%2fAQ%2f86d023fc-797b-4144-bcc5-535aee275e84%2f1%2f%5f6zPxeiWbE
This summary was completed on 25 March 2024. Newer information since this summary was written may now exist. This summary includes only results from one single study. Other studies may find different results.REC name
Wales REC 1
REC reference
21/WA/0131
Date of REC Opinion
9 Jun 2021
REC opinion
Further Information Favourable Opinion