Efficacy and Tolerability Study of Avanafil in Russia

NCT02503306 | Completed Phase 3

• 2 other identifiers: AVANAL07163U1111-1167-6889
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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 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: o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction (ED).

Conditions

Sexual Function and Fertility Disorders NEC-Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse

  12 weeks

• Change in the percentage of sexual attempts in which subjects are able to insert the penis into the partner's vagina

  8 weeks

• Change from baseline in EF score

  baseline and 8 weeks

Secondary Outcomes (2)

• Change from baseline in IIEF-EF risk scores

  baseline and 8 weeks

• Proportion of patients with adverse events

  12 weeks

Study Arms (3)

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

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

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

Drug: placebo

Interventions

AVANAFIL DRUG

Pharmaceutical form:tablets Route of administration: oral

Avanafil dose 1; Avanafil dose 2

placebo DRUG

Pharmaceutical form:tablets Route of administration: oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Moscow, Russia

Location

MeSH Terms

Interventions

avanafil

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

RU (1)