Testosterone Pellets Plus Vitamin D and E Versus Vitamin... | NCT01578473

Studies
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease

NCT01578473

Sponsor

Men's Health Boston

Status

Completed

Last Update Posted

Mar 29, 2018Actual

Enrollment

75Actual

Phase

Phase 1

Conditions

Peyronie's Disease

Interventions

Vitamin D2
Vitamin E
Testosterone Pellets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SAIRB #201107293	Other Identifier	Schulman Associates Institutional Review Board, Inc.

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2013Actual

Primary Completion Date

Jul 7, 2013Actual

Completion Date

Nov 13, 2017Actual

First Submitted Date

Apr 12, 2012

First Submission Date that Met QC Criteria

Apr 16, 2012

First Posted Date

Apr 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2018

Last Update Posted Date

Mar 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D and E	Active Comparator	Oral Vitamin D and E alone in men with penile curvature due to PD.	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.	Drug: Testosterone Pellets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D2	Drug	oral softgel 2000 IU once daily 9 months	Vitamin D and E

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
penile curvature	The primary outcome to be assessed will be the change in penile curvature from baseline.	9 months

Secondary Outcomes

Measure	Description	Time Frame
sexual function	Secondary outcomes will incluce overall satisfaction with sexual function (patient satisfaction with treatment, quality of erections and quality of life).	9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010409	Penile Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D004872	Ergocalciferols
D014810	Vitamin E
D013739	Testosterone

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds