Sexual Function and Fertility Disorders NEC-Erectile DysfunctionPhase 3CEDARNCT02503306
Efficacy and Tolerability Study of Avanafil in Russia
A Phase 3 study testing AVANAFIL in people with Sexual Function and Fertility Disorders NEC-Erectile Dysfunction, run by Sanofi at 1 site in Russia.
Trial summary
Primary Objective: o To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period: The change in percent of sexual attempts in which subjects are able to insert the penis into… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sexual Function and Fertility Disorders NEC-Erectile Dysfunction
- What is being tested?
- AVANAFIL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2015to Mar 2016
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects, age ≥18 years.
- Minimum 6-month history of mild to severe erectile dysfunction prior to the enrollment into the study.
- Subject is in a monogamous, heterosexual relationship for at least 3 months prior to the enrollment into the study.
- Subject agrees to make at least 4 sexual intercourse attempts per month.
- Subject is willing and able to provide informed consent.
Who cannot join
- Allergy or hypersensitivity to avanafil, sildenafil, vardenafil, tadalafil, or any of the components of these drug products.
- History of dose-limiting adverse effects during therapy with a phosphodiesterase-5 (PDE5) inhibitor or history of consistent treatment failure with other PDE5 inhibitors for therapy of ED.
- Current or expected use of organic nitrates at any time during the study.
- Previous or current (including while on treatment) antiandrogen therapy.
- Use of ketoconazole, erythromycin, cimetidine, or any other prescription or over-the-counter drugs known to inhibit the activity of cytochrome P450 (CYP) 3A4 within 28 days prior to randomization or at any time during this study.
- Androgen replacement therapy that has not been stable for at least 3 months.
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- Erectile dysfunction as a result of spinal cord injury or radical prostatectomy.
- Untreated hypogonadism or serum total testosterone <325 ng/dL (early morning collection).
- History of or predisposition to priapism (such as sickle cell disease, blood dyscrasias, or multiple myeloma).
- Uncontrolled hypertension as evidenced by systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg at screening.
- Hypotension as evidenced by systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg at screening.
- Orthostatic hypotension as evidenced by reduction of 20 mmHg or more in systolic blood pressure, reduction of 10 mmHg or more in diastolic blood pressure, or evidence of cerebral hypoperfusion upon standing from a seated position.
- Clinically evident penile lesions, abrasions, anatomical deformities such as penile fibrosis, Peyronie's disease, urinary tract or bladder infection, or sexually transmissible disease that the Investigator deems to be clinically significant.
- History of drug, alcohol, or substance abuse within 12 months of entry.
- Partners who are <18 years of age, who are nursing, who are known to be pregnant at screening, who wish to become pregnant during the study period, who have dyspareunia, and/or any other gynecologic problems or major medical conditions that would limit participation in sexual intercourse.
- Evidence of any clinically significant medical, psychiatric, social, or other condition by history, physical examination, or laboratory studies that, in the opinion of the Investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity, or confound the interpretation of study results.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia
Primary Objective:
- To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period:
- The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina.
- The change in score on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire.
Secondary Objective:
- To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction (ED).
Read the detailed description
The total study duration per patient will be up to 12 weeks, consisting of an 8-week treatment period and a 4-week run-in period.
- Being tested
- AVANAFIL, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVANAFILDrug
Pharmaceutical form:tablets Route of administration: oral
placeboDrug
Pharmaceutical form:tablets Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Avanafil dose 1 | Experimental | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period Receives: Drug: AVANAFIL |
| Avanafil dose 2 | Experimental | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period Receives: Drug: AVANAFIL |
| Placebo | Placebo comparator | Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse
Measured: 12 weeks
Change in the percentage of sexual attempts in which subjects are able to insert the penis into the partner's vagina
Measured: 8 weeks
Change from baseline in EF score
Measured: baseline and 8 weeks
Secondary outcomes (2)
Change from baseline in IIEF-EF risk scores
Measured: baseline and 8 weeks
Proportion of patients with adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Function and Fertility Disorders NEC-Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503306
- Sponsor's protocol ID
- AVANAL07163
- Other IDs
- U1111-1167-6889
- Acronym
- CEDAR
- Status last verified
- Mar 2016
- First submitted
- 17 Jul 2015
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia
- ClinicalTrials.gov ID
- NCT02503306
- Acronym / sponsor ID
- CEDAR / AVANAL07163
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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.
Primary Objective:
- To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period:
- The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina.
- The change in score on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire.
Secondary Objective:
- To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction (ED).
Detailed description
The total study duration per patient will be up to 12 weeks, consisting of an 8-week treatment period and a 4-week run-in period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Avanafil dose 1 | Experimental | Drug: AVANAFILAdministered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Avanafil dose 2 | Experimental | Drug: AVANAFILAdministered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
| Placebo | Placebo comparator | Drug: placeboAdministered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male subjects, age ≥18 years.
- Minimum 6-month history of mild to severe erectile dysfunction prior to the enrollment into the study.
- Subject is in a monogamous, heterosexual relationship for at least 3 months prior to the enrollment into the study.
- Subject agrees to make at least 4 sexual intercourse attempts per month.
- Subject is willing and able to provide informed consent.
Key exclusion criteria (17 listed)
- Allergy or hypersensitivity to avanafil, sildenafil, vardenafil, tadalafil, or any of the components of these drug products.
- History of dose-limiting adverse effects during therapy with a phosphodiesterase-5 (PDE5) inhibitor or history of consistent treatment failure with other PDE5 inhibitors for therapy of ED.
- Current or expected use of organic nitrates at any time during the study.
- Previous or current (including while on treatment) antiandrogen therapy.
- Use of ketoconazole, erythromycin, cimetidine, or any other prescription or over-the-counter drugs known to inhibit the activity of cytochrome P450 (CYP) 3A4 within 28 days prior to randomization or at any time during this study.
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 |
|---|---|---|
| AVANAFILPharmaceutical form:tablets Route of administration: oral | Drug | Avanafil dose 1, Avanafil dose 2 |
| placeboPharmaceutical form:tablets Route of administration: oral | Drug | Placebo |
Primary outcome
Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse
Time frame: 12 weeks
Change in the percentage of sexual attempts in which subjects are able to insert the penis into the partner's vagina
Time frame: 8 weeks
Change from baseline in EF score
Time frame: baseline and 8 weeks
2 secondary outcomes
Change from baseline in IIEF-EF risk scores
Time frame: baseline and 8 weeks
Proportion of patients with adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AVANAFIL in people with Sexual Function and Fertility Disorders NEC-Erectile Dysfunction, run by Sanofi at 1 site in Russia.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 17 Mar 2016.