Depression Related Improvement With Vardenafil for Erectile Response
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction; Depression
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The study will last three months. During the first month of treatment the subject will
receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose
to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will
again evaluate, after 2 months of treatment if the subject wants to increase the dosage from
10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg
or 5 mg. It will not be possible after this point to increase or decrease the dosage for the
rest of the study. The subject will be asked to attend the clinic on four separate occasions
over a period of 3 months. Every visit will last about 1 hour. At the first visit the
doctor will ask the subject about their medical history, and the subject will be given a
medical examination (including your heart rate, blood pressure and weight). The medical
examination will also include an ECG. The subject will be asked to provide a blood and urine
sample, which will be analysed and screened for drugs of potential abuse (e. g.cocaine,
narcotics, sedatives, hypnotics). The subject will then be asked to fill in a questionnaire
about their mood and feelings. The subject qualifies, they will have an interview with a
trained mental health care provider who will assess their level of depression. At the end of
the visit, the doctor will provide the subject with a diary in which they must record details
about their attempts at sexual activity during the next 4 weeks. The subject will be asked to
make at least 4 attempts at sexual intercourse on 4 separate days and to record the attempts
in the diaries. After 4 weeks the subject will return to the clinic. They will be asked to
fill in different questionnaires about their sexuality, mood and feelings, general quality of
life, self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine
samples will be collected. An interview with the trained mental health care provider who will
re-assess their level of depression. At this visit all information collected so far will be
assessed and the doctor will check to see if the requirements to enter the treatment period
are fulfilled. The subject may be excluded from further participation in the study, for
example due to results of the blood analysis or if your level of depression did not meet the
criteria for the study. If the subject is able to participate to the study they will be given
the study drug. At each visit, adverse events will be discussed and whether there is any
change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or
Premature Termination. At every visit the subject will receive a diary in which they must
record details about their attempts at sexual activity during the period between each visit
and the number of tablets taken. Subjects will also be asked to fill in different
questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity.
Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study
medication, 24 hours after the last dose of study medication. The doctor will give the study
drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the
subject will be required to return to the clinic for a physical examination, vital signs and
have blood samples and ECG obtained. They will also be asked to fill in different
questionnaires.
Clinical Details
Official title: A Randomized Double-Blind Multi-Center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy variables are the change from baseline in the IIEF-EF domain score and the change from baseline in the HAM-D17 total score.
Secondary outcome: Patient Diary questions of treatment compared to placebo.Global assessment question (GAQ) of treatment compared to placebo. The scores for the IIEF questionnaire. Responses on the Center for Epidemiologic Studies Depression Scale (CES-D). Responses on the Rosenberg Self Esteem Scale. Responses on the Clinical Global Impressions scale, Items 1 and 2. Reliability in early responders. Other IIEF domain scores than EF domain score at 12 weeks. Safety assessment
Detailed description:
- Percent of subjects who achieve a decrease of >3. 5 points on the HAM-D17 total score on
vardenafil or placebo.
- Percent of "responders" who achieve a decrease of 50% or more on the HAM-D17 total score
on vardenafil or placebo.
- Percent or "remitters" who achieve a score of 7 or less on the HAM-D17 total score on
vardenafil or placebo.
Any patient who takes at least one dose of study will be included in the evaluation of
safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Erectile dysfunction for more than 6 months according to the NIH Consensus statement
(the inability to attain and maintain erection of the penis sufficient to permit
satisfactory sexual intercourse).
- Stable, heterosexual relationship for more than 6 months.
- Diagnosis of mild Major Depressive Disorder using a structured interview (SCID-1 or
MINI), according to DSM-IV criteria. Before randomization, a psychiatrist must
interview the subject at Visit 2 to validate both the diagnosis of MDD and the
subject's continuation in the study without the need for anti-depressant medication or
psychotherapy).
- Patients must score greater than 13 on the CES-D at Visit 1.
- Patients must score between 11 and 17 on the 17-item HAM-D at Visit 1 and Visit 2.
- The patient must make at least four attempts at sexual intercourse on four separate
days during the untreated baseline period
- At least 50% of the attempts of sexual intercourse during the untreated baseline
period have to be unsuccessful
Exclusion Criteria:
Previous or Current Medical Conditions
- Any unstable medical condition or substance abuse disorder that, in the opinion of the
Investigator, is likely to affect the patient's ability to complete the study or
precludes the patient's participation in the study.
- Patients who score > 0 on item #3 on the HAM-D17 or men who, in the investigator's
judgement, pose a current serious suicidal or homicidal risk or have made a suicide
attempt within the past 12 months.
- Men with a current (or within 6 months prior to screening) Axis 1 disorder other than
MDD (major depressive disorder). Patients with a history, or who currently meet the
DSM-IV criteria, of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder,
Delusional (Paranoid) Disorder, Panic Disorder, Post-Traumatic Stress Disorder.
Patients with a Personality Disorder are excluded if, in the investigator's opinion,
it will interfere with the conduct of the trial.
- Retinitis pigmentosa.
- Unstable angina pectoris.
- History of radical prostatectomy.
- History of myocardial infarction, stroke, electrocardiographic ischemia (except stable
angina), or life-threatening arrhythmia within the prior 6 months.
Abnormal Laboratory Values
- AST or ALT > 3 times the upper limit of normal Concomitant Medications
- Patients who are taking nitrates or nitric oxide donors (e. g., molsidomine,
minoxidil). Topical minoxidil is permitted.
- Patients who are taking androgens (e. g., testosterone) or anti-androgens.
- Patients taking trazodone, or any other anti-depressant including monoamine oxidase
inhibitors, St. John's Wort, SSRIs or tricyclic anti-depressants are excluded, or use
of these medications in the last 2 weeks before Visit 1. Fluoxetine is excluded in
the last 4 weeks before Visit 1.
- Patients who are taking the following potent inhibitors of cytochrome P 450 3A4: the
HIV protease inhibitors ritonavir and indinavir, erythromycin or the anti-mycotic
agents itraconazole and ketoconazole (topical forms are allowed).
- Subjects who are taking alpha-blockers.
- Use of any therapy for erectile dysfunction within seven days of Visit 1 and during
the trial.
- Patients who require, or are likely to require, treatment with psychotherapy or
psychotropic drugs during the course of the study. Men receiving formal individual
psychotherapy for depression currently or in the 12 weeks prior to screening visit.
Abnormal Laboratory Values
- Patients who have a serum total testosterone level >10% below the lower limit of
normal (according to the range specified by the responsible laboratory).
Other Exclusions
- Patients whose urine screen for substances of abuse is positive.
- Patients unwilling to refrain from consuming grapefruit juice or products containing
grapefruit juice with study medication.
Locations and Contacts
Vancouver V5Z 1M9, Canada
LYON 69000, France
LYON CEDEX 69437, France
LYON 69007, France
NICE 06200, France
MARSEILLE 13008, France
MARSEILLE 13006, France
PARIS 75009, France
MARSEILLE 13275, France
LILLE 59000, France
NANTES 44000, France
Milano 20132, Italy
Padova 35128, Italy
Milano 20122, Italy
Bari 70124, Italy
Roma 00155, Italy
Firenze 50139, Italy
Milano 20123, Italy
Napoli 80131, Italy
Modena 41100, Italy
Pisa 56126, Italy
Barcelona 08036, Spain
Madrid 28007, Spain
Sevilla 41013, Spain
Zaragoza 50009, Spain
Huntsville, Alabama 35801, United States
Anchorage, Alaska 99508, United States
Edmonton, Alberta T5K 2K5, Canada
San Diego, California 92101, United States
Beverly Hills, California 90212, United States
Irvine, California 92618-3603, United States
La Mesa, California 91942-3058, United States
Aventura, Florida 33180, United States
Atlanta, Georgia 30308, United States
Boston, Massachusetts 02118, United States
New Brunswick, New Jersey 08901, United States
New York, New York 10021-4885, United States
Markham, Ontario L6B 1A1, Canada
Hamilton, Ontario L8M 1K7, Canada
Toronto, Ontario M9W 4L6, Canada
Ottawa, Ontario K1G 4G3, Canada
Montreal, Quebec H2X 1N8, Canada
Hull, Quebec J9A 1K7, Canada
Montreal, Quebec H3G 1A4, Canada
Sherbrooke, Quebec JIH 4J6, Canada
Charlottesville, Virginia 22908, United States
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: December 2002
Ending date: November 2003
Last updated: April 17, 2008
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