NCT01327495

Brief Summary

The investigators will conduct a three-month, randomized, placebo-controlled trial comparing the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the prostate in healthy men who are treated with acyline to block gonadal androgen production.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_2 healthy

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2017

Completed
Last Updated

October 5, 2017

Status Verified

September 1, 2017

Enrollment Period

2.7 years

First QC Date

March 21, 2011

Results QC Date

February 15, 2017

Last Update Submit

September 7, 2017

Conditions

Healthy

Keywords

Androgen replacement in men

Outcome Measures

Primary Outcomes (4)

  • Prostate Tissue DHT Concentrations After Treatment

    To measure intraprostatic dihydrotestosterone \[DHT\] levels

    12 weeks

  • Serum Testosterone

    12 weeks

  • Dihydrotestosterone (DHT)

    12 weeks

  • Prostate Tissue Testosterone Concentrations After Treatment

    To measure intraprostatic testosterone levels

    12 weeks

Secondary Outcomes (3)

  • Prostate Specific Antigen

    12 weeks

  • Prostate Volume

    12 weeks

  • International Prostate Symptom Score (IPSS)

    12 weeks

Other Outcomes (7)

  • 17-OHPreg

    12 weeks

  • 17-OHP

    12 weeks

  • Androstenedione

    12 weeks

  • +4 more other outcomes

Study Arms (6)

Arm 1: Placebo

PLACEBO COMPARATOR

Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks

Other: placebo acylineOther: placebo gel

Arm 2:1.25g Testosterone

ACTIVE COMPARATOR

Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks

Drug: Testosterone 1% gel 1.25 gDrug: Acyline

Arm 3: 2.5g Testosterone

ACTIVE COMPARATOR

Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks

Drug: Testosterone 1% gel 2.5 gDrug: Acyline

Arm 4: 5g Testosterone

ACTIVE COMPARATOR

Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks

Drug: Testosterone 1% gel 5.0 gDrug: Acyline

Arm 5: 10g Testosterone

ACTIVE COMPARATOR

Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks

Drug: testosterone 1% gel 10 gDrug: Acyline

Arm 6: 15g Testosterone

ACTIVE COMPARATOR

Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks

Drug: testosterone 1% gel 15 gDrug: Acyline

Interventions

placebo acylineOTHER

Placebo acyline subcutaneous injection every 2 weeks

Also known as: placebo
Arm 1: Placebo
placebo gelOTHER

daily placebo testosterone gel applied transdermally x 12 weeks

Also known as: placebo
Arm 1: Placebo
Testosterone 1% gel 1.25 gDRUG

testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks

Also known as: Androgel
Arm 2:1.25g Testosterone
Testosterone 1% gel 2.5 gDRUG

Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks

Also known as: Androgel
Arm 3: 2.5g Testosterone
Testosterone 1% gel 5.0 gDRUG

Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks

Also known as: Androgel
Arm 4: 5g Testosterone
testosterone 1% gel 10 gDRUG

Testosterone 1% gel 10 g daily applied transdermally x 12 weeks

Also known as: Androgel
Arm 5: 10g Testosterone
testosterone 1% gel 15 gDRUG

Testosterone 1% gel 15 g daily applied transdermally x 12 weeks

Also known as: Androgel
Arm 6: 15g Testosterone
AcylineDRUG

300 ug/kg subcutaneous injection every 2 weeks

Also known as: GNRH antagonist
Arm 2:1.25g TestosteroneArm 3: 2.5g TestosteroneArm 4: 5g TestosteroneArm 5: 10g TestosteroneArm 6: 15g Testosterone

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good health, without severe systemic illness (i.e., renal, liver, cardiac or lung disease, cancer, insulin dependent diabetes)
  • Male between the ages of 25 and 55 years old
  • Able to understand and comply with protocol instructions and requirements
  • International Prostate Symptom Score (IPSS) \<11
  • Agrees to not donate blood during the study
  • Normal serum total T, LH, FSH, urine analysis, COMP, CBC and sperm count

You may not qualify if:

  • History of, or current breast cancer or prostate cancer
  • Clinically significant findings on digital rectal exam such as nodules, areas of induration or any other malignancy or abnormal prostate ultrasound
  • History of invasive therapy for BPH
  • Current or past treatment with a 5α-reductase inhibitor
  • History of drug or alcohol abuse within the past 12 months
  • History of a bleeding disorder or anticoagulation
  • Skin disease that might interfere with T-gel absorption
  • Participation in another drug study in the past 3 months
  • A first-degree relative (i.e. father, brother) with a history of prostate cancer
  • History of infertility or desire for fertility within 6 months, or current pregnant female partner
  • Weight \>320 pounds or BMI \> 40
  • PSA Level \> 2.1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Thirumalai A, Cooper LA, Rubinow KB, Amory JK, Lin DW, Wright JL, Marck BT, Matsumoto AM, Page ST. Stable Intraprostatic Dihydrotestosterone in Healthy Medically Castrate Men Treated With Exogenous Testosterone. J Clin Endocrinol Metab. 2016 Jul;101(7):2937-44. doi: 10.1210/jc.2016-1483. Epub 2016 May 12.

    PMID: 27172434RESULT

MeSH Terms

Interventions

TestosteroneGelsacylineLHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Stephanie Page, MD, PhD
Organization
University of Washington
page@uw.edu
206-616-0483

Study Officials

  • Stephanie T Page, MD, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Department of Medicine, Division of Metabolism, Endocrinology and Nutrition

Study Record Dates

First Submitted

March 21, 2011

First Posted

April 1, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

October 5, 2017

Results First Posted

October 5, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)