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Erectile DysfunctionPhase 2/3TD0025NCT02798159

Safety and Efficacy of TD0025 (Rocket1h) for Treatment of Erectile Dysfunction

A Phase 2/3 study testing TD0025 and Sildenafil Citrate 50mg in people with Erectile Dysfunction, run by Vietstar Biomedical Research at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil Citrate taken as needed over one month (phase… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Erectile Dysfunction
What is being tested?
TD0025 and Sildenafil Citrate 50mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteVietnam
Study dates
May 2016to 1 Jul 2018
Phase
Phase 2/3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • History of Erectile Dysfunction (ED) of at least 1 month duration.
  • Anticipate having the same adult female sexual partner during the study.
  • Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.
  • Sign the informed consent form

Main Exclusion Criteria:

  • ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity
  • ED caused by untreated or inadequately treated endocrine disease
  • Current treatment with doxazocin, nitrates, cancer chemotherapy, or anti-androgens
  • Severe renal or hepatic impairment, history of malignant hypertension
  • Presence or history of specific heart conditions

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Men Sexual Health Centre; Vietnam- Germany Hospital

    Hanoi

Other trials in Vietnam

About this study

Official title: A Randomized, Placebo Control, Double-blinded, Double-dummy, Phase 2/3 Combination Study to Evaluate the Safety and Efficacy of TD0025 (Rocket1h) Compared With Sildenafil Citrate for Treatment of Erectile Dysfunction

The purpose of this study is to identify the optimal dose(s) of TD0025 for treatment of erectile dysfunction (phase II) and to investigate if treatment of erectile dysfunction with the optimal dose of TD0025 taken as needed over one month is non-inferior than Sildenafil Citrate taken as needed over one month (phase III)

Being tested
TD0025, Sildenafil Citrate 50mg
Keywords
Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders, Sildenafil
Medical subject headings
Erectile Dysfunction, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TD0025Drug

  • Sildenafil Citrate 50mgDrug

Study groups in NCT02798159
Study groupRoleWhat they receive
Part A- Arm 1ExperimentalInvestigational dose = 0.25 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Receives: Drug: TD0025
Part A- Arm 2ExperimentalInvestigational dose = 0.5 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Receives: Drug: TD0025
Part A- Arm 3ExperimentalInvestigational dose = 1 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Receives: Drug: TD0025
Part A- Arm 4ExperimentalInvestigational dose = 1.25 time of the expected dose. The drug should not be taken more than one time a day or 3 times a week Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month.
Receives: Drug: TD0025
Part B- Arm 1ExperimentalInvestigational dose = optimal dose in Part A. The drug should not be taken more than one time a day or 3 times a week. Drug: TD0025 Administered orally once a day, 5 hours before sexual activity, for 1 month
Receives: Drug: TD0025
Part B- Arm 2Active comparatorSildenafil Citrate 50 mg on demand The drug should not be taken more than one time a day or 3 times a week. Administered orally once a day, 1 hour before sexual activity, for 1 month
Receives: Drug: Sildenafil Citrate 50mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4

    Measured: Baseline, 4 weeks

  2. PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain

    Measured: Baseline, 4 weeks

Secondary outcomes (19)

  1. PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Erectile Function (EF) Domain

    Measured: Baseline, 4 weeks

  2. PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain

    Measured: Baseline, 4 weeks

  3. PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain

    Measured: Baseline, 4 weeks

  4. PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain

    Measured: Baseline, 4 weeks

  5. PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain

    Measured: Baseline, 4 weeks

  6. PART A- PHASE II: The percentage of patients with abnormal Testosterone, FSH, LH and Androgen Serum Levels at Baseline and after 4 weeks of treatment

    Measured: Baseline, 4 weeks

  7. PART A- PHASE II: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment

    Measured: Baseline, 4 weeks

  8. PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Orgasmic Function Domain

    Measured: Baseline, 4 weeks

  9. PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Sexual Desire Domain

    Measured: Baseline, 4 weeks

  10. PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Intercourse Satisfaction Domain

    Measured: Baseline, 4 weeks

  11. PART B- PHASE III: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), Overall Satisfaction Domain

    Measured: Baseline, 4 weeks

  12. PART B- PHASE III: Time to Discontinuation of Randomized Treatment

    Measured: Baseline up to 30 days

  13. PART B- PHASE III: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4 Weeks

    Measured: 4 weeks

  14. PART B- PHASE III: Change From Baseline to 4 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire

    Measured: Baseline, 4 weeks

  15. PART B- PHASE III: Change From Baseline to 4 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire

    Measured: Baseline, 4 weeks

  16. PART B- PHASE III: Change From Baseline to 4 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire

    Measured: Baseline, 4 weeks

  17. PART B- PHASE III: Change From Baseline to 4 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire

    Measured: Baseline, 4 weeks

  18. PART B- PHASE III: The percentage of patients with abnormal Testosterone, FSH, LH and Androgen Serum Levels at Baseline and after 4 weeks of treatment

    Measured: Baseline, 4 weeks

  19. PART B- PHASE III: The percentage of patients with abnormal hematology and biochemistry laboratory values at baseline and after 4 weeks of treatment

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion1 Mar 2018
  4. Study completion1 Jul 2018

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02798159
Sponsor's protocol ID
TD0025
Acronym
TD0025
Status last verified
Jun 2016
First submitted
4 Jun 2016
Last updated
11 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TD0025 and Sildenafil Citrate 50mg in people with Erectile Dysfunction, run by Vietstar Biomedical Research at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 11 Oct 2018. 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 Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

PART A- PHASE II: Change From Baseline to 4 Weeks of the International Index of Erectile Function (IIEF), question # 3 and #4 (time frame: Baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02798159.

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 11 Oct 2018.

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