Peyronie's DiseasePhase 1PD+NCT01578473
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
A Phase 1 study testing Vitamin D2, Vitamin E and Testosterone Pellets in people with Peyronie's Disease, run by Men's Health Boston at 1 site in United States.
Trial summary
Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- Vitamin D2, Vitamin E and Testosterone Pellets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2013to 13 Nov 2017
- Phase
- Phase 1
- 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 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acquired penile curvature of > 30 degrees and < 90 degrees associated with palpable penile plaque on physical examination
- onset of curvature within 18 months prior to signing consent form
- serum TT < 500 ng/dl at the screening visit
Who cannot join
- prior history of treatment for PD that includes intra-lesional injections, topical creams, or surgery
- prior treatment with oral therapy at least 2 weeks prior to signing consent form (e.g. Potaba, Vitamin E, colchicines) will be acceptable for inclusion
- prior history of treatment for testosterone deficiency
- presence of dense calcified plaque by US or plain radiograph
- taking the medication Coumadin
- hypersensitivity to testosterone, stearic acid, or polyvinyl pyrolidone (the constituents of Testopel)
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- unable to achieve adequate erection with penile injection to access degree of curvature
- undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy.
- prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with human immunodeficiency virus, or psychiatric disorders including major depression, schizophrenia, bipolar disease
- history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
- PSA > 4.0 ng/dL at the screening visit, unless prostate cancer has been excluded to the investigator's satisfaction
- clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
- received any other investigational drug within 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Men's Health Boston
Chestnut Hill, Massachusetts, 02467
About this study
Official title: An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.
- Conditions
- Peyronie's Disease
- Being tested
- Vitamin D2, Vitamin E, Testosterone Pellets
- Keywords
- low testosterone, penile curvature
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Also called 21st Century Dietary Supplement
oral softgel 2000 IU once daily 9 months
Vitamin EDrug
Also called GERI-CARE
oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily
1 softgel of 200 IU daily 9 months
Testosterone PelletsDrug
Also called Testopel 75 mg testosterone pellets
subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and E | Active comparator | Oral Vitamin D and E alone in men with penile curvature due to PD. Receives: Drug: Vitamin D2; Drug: Vitamin E |
| Testosterone Pellets and Vitamin D and E | Active comparator | Testosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD. Receives: Drug: Testosterone Pellets |
What is being measured
The primary outcome is the main question the study is designed to answer.
penile curvature
The primary outcome to be assessed will be the change in penile curvature from baseline.
Measured: 9 months
Secondary outcomes (1)
sexual function
Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study start23 May 2013
- Primary completion7 Jul 2013
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Men's Health Boston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abraham Morgentaler, Men's Health Boston
- Investigators
- Abraham Morgentaler, MD, Principal investigator, Men's Health Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578473
- Sponsor's protocol ID
- PD Plus Study
- Other IDs
- SAIRB #201107293
- Acronym
- PD+
- Status last verified
- Mar 2018
- First submitted
- 12 Apr 2012
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Nine-Month Randomized Controlled Study of Testosterone (Testopel) Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease
- ClinicalTrials.gov ID
- NCT01578473
- Acronym / sponsor ID
- PD+ / PD Plus Study
- Conditions
- Peyronie's Disease
- Keywords
- low testosterone, penile curvature
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Men's Health BostonUniversity, hospital or other
- Study start
- 23 May 2013 (actual)
- Primary completion
- 7 Jul 2013 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 17 Apr 2012 (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.
Two recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and E | Active comparator | Drug: Vitamin D2, Drug: Vitamin EOral Vitamin D and E alone in men with penile curvature due to PD. |
| Testosterone Pellets and Vitamin D and E | Active comparator | Drug: Testosterone PelletsTestosterone in combination with oral Vitamin D an E supplementation in men with penile curvature due to PD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acquired penile curvature of > 30 degrees and < 90 degrees associated with palpable penile plaque on physical examination
- onset of curvature within 18 months prior to signing consent form
- serum TT < 500 ng/dl at the screening visit
Key exclusion criteria (13 listed)
- prior history of treatment for PD that includes intra-lesional injections, topical creams, or surgery
- prior treatment with oral therapy at least 2 weeks prior to signing consent form (e.g. Potaba, Vitamin E, colchicines) will be acceptable for inclusion
- prior history of treatment for testosterone deficiency
- presence of dense calcified plaque by US or plain radiograph
- taking the medication Coumadin
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 |
|---|---|---|
| Vitamin D2Also: 21st Century Dietary Supplementoral softgel 2000 IU once daily 9 months | Drug | Vitamin D and E |
| Vitamin EAlso: GERI-CAREoral softgels 400 IU and 200 IU 1 softgel of 400 IU daily 1 softgel of 200 IU daily 9 months | Drug | Vitamin D and E |
| Testosterone PelletsAlso: Testopel 75 mg testosterone pelletssubcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months | Drug | Testosterone Pellets and Vitamin D and E |
Primary outcome
penile curvature
Time frame: 9 months
The primary outcome to be assessed will be the change in penile curvature from baseline.
1 secondary outcome
sexual function
Time frame: 9 months
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 29 Mar 2018.
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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.
Abraham Morgentaler, MD principal investigator
Men's Health Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D2, Vitamin E and Testosterone Pellets in people with Peyronie's Disease, run by Men's Health Boston at 1 site in United States.
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 3 inclusion and 13 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 29 Mar 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 United States. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
penile curvature (time frame: 9 months). 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 29 Mar 2018.