EDC for erectile dysfunction clinical trials
An ED trial pairs a validated domain score with a per-attempt diary of what happened, runs a baseline period before dosing, and collects very private answers. Build the run-in, the attempt diary and the domain questionnaire in Capture, and test it free.
- Run-in and attempt diary
- IIEF-EF at scheduled visits
- Private phone-based answers
Free sandbox · No credit card · 21 CFR Part 11 compliant
weeks
Baseline
Week 12 on treatment
What an erectile dysfunction trial needs from its EDC
- A score and a diary, not one or the other: registered phase 3 trials of oral agents commonly report the change in a validated erectile function domain together with attempt-level success questions, usually at around week 12.
- Event-level data: the diary records each attempt, so a participant can generate dozens of rows. The unit of analysis is often the proportion of attempts that succeed.
- A baseline you can trust: a treatment-free run-in with a minimum number of attempts defines who is eligible and gives the comparison point.
- Dose timing: on-demand dosing means time of dose, time of attempt and the gap between them are data.
- Privacy by design: answers are intimate. Coded IDs, restricted access and plain consent language matter more here than in most indications.
The endpoint model
Domain score, SEP2 and SEP3: how the three primaries are built
Look at registered phase 3 trials of PDE5 inhibitors and the same trio of primary measures recurs. Trials of avanafil, including one in men after prostatectomy, used the change in the International Index of Erectile Function erectile function (IIEF-EF) domain together with two diary questions: SEP2, whether the attempt achieved vaginal penetration, and SEP3, whether the erection lasted long enough for successful intercourse. A registered vardenafil orally disintegrating tablet study named the IIEF-EF at week 12 as primary, with SEP2 and SEP3 co-primary, and required a share of participants to be aged 65 or older. An intracavernosal add-on registry entry used the same trio at month 3. Your own protocol may differ, and regulators set their own expectations, so do not borrow the design without checking the current guidance for your product.
The data structures are different. The domain score is a questionnaire answered with a recall window (commonly the previous four weeks), summed from item scores. The IIEF-EF domain is usually described as six items with a total from 1 to 30, but confirm that against the licensed version your protocol uses. The SEP diary is event-level: one record per attempt, with date, whether an attempt was made, and yes/no answers to SEP2 and SEP3. Build it as a short phone-friendly form the participant opens from a secure link, and add the dose time as a field so the analysis can relate dose to attempt. Capture does not claim event-triggered prompts, so instruct participants to complete the form after each attempt and use reminders for the rest.
The run-in defines the baseline. A typical design asks participants to log a minimum number of attempts over several weeks, then randomises those who still fail a stated share of attempts. Edit checks can flag participants who are approaching the end of the run-in without enough attempts, so the site can decide in time. The IIEF-EF, SEP and similar tools each have rights-holder terms; Capture does not supply instrument wording or verify licences, and licence controls exist only on participant questionnaires, with status stored as entered by the study team.
Sexual encounter diary entry (demo)
Participant 001-0043 · Treatment, week 5
Date of attempt
ATTDTStudy medication taken before this attempt
DOSEDTime taken
DOSETMWas penetration achieved?
SEP2Did the erection last long enough for successful intercourse?
SEP3Consistent with SEP2
Protocol to build
Erectile dysfunction protocol elements and where they live in Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Duration and cause of ED, relationship status, prior PDE5 response, cardiovascular and nitrate exclusions | Screening form with skip logic; eligibility form |
| Run-in diary | Attempts logged, minimum attempts, baseline success rate | Participant phone form; completion view for site staff |
| Domain questionnaire | Item scores, domain total, recall window | Participant questionnaire at baseline and scheduled visits; total as a read-only calculated field |
| Global assessment questions | Did treatment improve erections? yes/no | Single-choice fields at the end-of-treatment visit |
| Dosing | Dispensed supply, tablets returned, on-demand use | Medication adherence and pill count capture |
| Cardiovascular safety | Blood pressure, heart rate, nitrate use, headache, flushing, visual symptoms | Vital signs form; adverse event form |
| Hormones and labs | Testosterone, glucose, lipids at screening | Lab data and reference ranges |
| Subgroups | Diabetes, post-prostatectomy, age bands | Stratification fields; see diabetes EDC and prostate cancer EDC for neighbouring populations |
Instrument wording is yours to supply. Licences stay with your study documents.
Build the attempt diary and domain form together
Create the run-in diary, the scheduled questionnaire and the consistency checks, then enter test data. Free sandbox, no credit card.
Operations
Privacy, partner questions and diary compliance
People answer sensitive questions more honestly when they trust where the answers go. In Capture, participants open their questionnaires from a secure link in the phone browser with no app to install, researchers can work from coded IDs with names held back through PII segregation, and the audit trail records every change. Write the consent form in plain language, say clearly who at the site can see what, and avoid collecting more than the endpoint needs. If your design includes partner-reported questions, decide early whether the partner is a participant with their own consent or simply a source of information, and what the ethics committee requires.
Diary compliance decides the primary result. A participant who stops logging at week 6 leaves you with a missing-data problem that no statistic fully repairs. Use reminders, check completion at each visit, and design the form so that a "no attempt this week" answer is quick to enter; otherwise silence is ambiguous (no attempts, or no diary). Compliance monitoring is described in ePRO compliance and diary completion rates.
Safety deserves its own attention. PDE5 inhibitors interact with nitrates, which is a standard exclusion, and the protocol will list headache, flushing, dyspepsia, visual disturbance and sudden hearing change among the events to watch, as the product information dictates. Build a conmed check that flags a nitrate entry against an active participant. For events that meet seriousness criteria, use the SAE workflow and the SAE reporting timelines guide. This page is not medical advice; the protocol and investigator decide what is safe.
Before first participant
Erectile dysfunction study readiness checklist
Instruments and licences filed
Domain questionnaire, diary questions and any satisfaction measure, with rights-holder terms in study documents.
Run-in rule written
Minimum attempts, length, and who decides eligibility after the run-in.
Diary consistency checks tested
SEP3 against SEP2, impossible dates, duplicate entries.
Nitrate and interaction check built
Concomitant medication check against a defined drug list.
Privacy plan agreed
Who sees names, who sees answers, and partner involvement.
Reminder schedule set
Diary reminders and a site call rule for a participant who goes quiet.
Can Capture score the IIEF-EF domain?
It can show a total as a read-only calculated field from typed item scores. You supply the licensed wording and confirm the scoring rule; Capture does not provide the instrument or verify its licence.
Can participants log each attempt?
Yes, as a short phone questionnaire opened from a secure link, with no app install. Capture does not claim event-triggered notifications, so give participants clear instructions and reminders.
How do we relate dose time to the attempt?
Add dose time and attempt time to the diary form. A calculated field can show the minutes between two date-times, and the export carries both.
Is the data private?
Participants use coded IDs in the study data, PII is segregated by role, and every change is audited. Capture is HIPAA compliant and GDPR compliant, with EU (Frankfurt) and US (N. Virginia) hosting.
Can we run a post-prostatectomy or diabetes subgroup?
Yes, as stratification and subgroup fields at screening. The randomisation and analysis plan are set by your statistician.
Does it support long-term extension?
Yes, epochs let a double-blind period and an open-label extension sit in one study. See long-term extension study software.
What does it cost?
The sandbox is free with every feature, no credit card. Plans for live studies are on the pricing page.
Keep exploring
Related pages
EDC for diabetes clinical trials
A common ED subgroup.
EDC for prostate cancer trials
Post-treatment function outcomes.
ePRO compliance and diary completion
Keeping diaries complete.
Medication adherence and pill count
On-demand dosing records.
Long-term extension software
Open-label follow-on.
Pricing
Plans and go-live rates.
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