NCT00163566

Brief Summary

The purpose of this study is to evaluate whether DHT-Gel, when applied daily to the skin, can relieve the symptoms of low testosterone in men aged 55-80. These symptoms include reduced muscle strength, increase fat mass, low libido, feeling blue or moody

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

16 active sites

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

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2006

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

September 9, 2005

Last Update Submit

August 11, 2022

Conditions

HypogonadismLate Onset HypogonadismLow Testosterone

Keywords

libidodepression strengthtestosteronedihydrotestosterone

Outcome Measures

Primary Outcomes (1)

  • Change in Body Composition

Secondary Outcomes (2)

  • Change in sexual libido, and overall function and mood

  • Normalization of serum androgen levels

Study Arms (3)

Placebo gel

PLACEBO COMPARATOR

Placebo gel twice per day

Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel

0.7% DHT gel, Dose 1

ACTIVE COMPARATOR

0.7% DHT gel twice per day, 35 mg/day

Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel

0.7% DHT gel, Dose 2

ACTIVE COMPARATOR

0.7% DHT gel twice per day, 70 mg/day

Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel

Interventions

Dihydrotestosterone (0.7%) in hydroalcoholic gelDRUG

transdermal gel, 0.7% DHT, 0.35 mg/day or 0.70 mg/day total daily dose (or placebo gel), applied twice per day

0.7% DHT gel, Dose 10.7% DHT gel, Dose 2Placebo gel

Eligibility Criteria

Age55 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged 55-80 Serum Testosterone \< 275 Symptoms of Hypogonadism as determined by AMS scale In good overall health

You may not qualify if:

  • Abnormal Prostate Exam for age Prostate or Breast Cancer Significant illness Weight \>300lbs Generalized skin disease Unstable sleep apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Radiant Research - Phoenix

Phoenix, Arizona, 85013, United States

Location

Harbor UCLA Medical Reserach and Education Institute

Torrance, California, 90502, United States

Location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

Genesis Research Consultants

Longwood, Florida, 32779, United States

Location

Pensacola Research Consultants

Pensacola, Florida, 32503, United States

Location

North Indiana Research

Fort Wayne, Indiana, 46825, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Bethesda Health Research

Bethesda, Maryland, 20817, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health Sciences Center

Portland, Oregon, 97239, United States

Location

VA Medical Center

Houston, Texas, 77030, United States

Location

Radiant Research - San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84108, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

VA Puget Sound Health Care

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Dihydrotestosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Neta R Nelson

    ASCEND Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 2004

Primary Completion

September 1, 2006

Study Completion

September 25, 2006

Last Updated

August 15, 2022

Record last verified: 2022-08

Locations

US(16)