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NCT00661219 · ClinicalTrials.gov registry record · Phase 3
Depression Related Improvement With Vardenafil for Erectile Response
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
NCT00661219: Completed Phase 3 study, sponsored by Bayer.
NCT00661219 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 280 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00661219, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
Study 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 provid
Interventions
- DRUG Placebo
- DRUG Levitra (Vardenafil, BAY38-9456)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2002-12 |
| Est. Completion | 2003-11 |
| Phase | Phase 3 |
What the finished NCT00661219 record still lists
NCT00661219 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00661219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00661219 about?
NCT00661219 is a clinical study titled "Depression Related Improvement With Vardenafil for Erectile Response". 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 mont...
What is the current status of trial NCT00661219?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2002-12. Estimated completion is 2003-11.
What interventions are being tested in trial NCT00661219?
The interventions under investigation include: Placebo (DRUG), Levitra (Vardenafil, BAY38-9456) (DRUG).
Who is sponsoring clinical trial NCT00661219?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00661219's enrollment target sits among peer trials
280 1195th of 2000 higher than 802 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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