HypogonadismPhase 2NCT00163566
Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80
A Phase 2 study testing Dihydrotestosterone (0.7%) in hydroalcoholic gel in people with Hypogonadism and Late Onset Hypogonadism, run by ASCEND Therapeutics at 16 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 80 years, men only
- Conditions the study is for
- Hypogonadism, Late Onset Hypogonadism, Low Testosterone
- What is being tested?
- Dihydrotestosterone (0.7%) in hydroalcoholic gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 16 sitesUnited States
- Study dates
- Oct 2004to 25 Sep 2006
- Phase
- Phase 2
- 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 55 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 55-80 Serum Testosterone < 275 Symptoms of Hypogonadism as determined by AMS scale In good overall health
Who cannot join
- Abnormal Prostate Exam for age Prostate or Breast Cancer Significant illness Weight >300lbs Generalized skin disease Unstable sleep apnea
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Bethesda Health Research
Bethesda, Maryland, 20817
Duke University Medical Center
Durham, North Carolina, 27710
North Indiana Research
Fort Wayne, Indiana, 46825
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
VA Medical Center
Houston, Texas, 77030
Genesis Research Consultants
Longwood, Florida, 32779
University of Louisville
Louisville, Kentucky, 40202
Pensacola Research Consultants
Pensacola, Florida, 32503
Radiant Research - Phoenix
Phoenix, Arizona, 85013
Oregon Health Sciences Center
Portland, Oregon, 97239
McGuire VA Medical Center
Richmond, Virginia, 23249
University of Utah School of Medicine
Salt Lake City, Utah, 84108
Radiant Research - San Antonio
San Antonio, Texas, 78229
VA Puget Sound Health Care
Seattle, Washington, 98108
Harbor UCLA Medical Reserach and Education Institute
Torrance, California, 90502
About this study
Official title: A Phase II, Placebo-Controlled, Double-Blind, Dose-Ranging (35mg/Day or 70 mg/Day), Randomized, Study of Cutaneous Dihydrotestosterone (DHT)-Gel (0.7% Hydroalcoholic Gel) in Older Hypogonadal Males Ages 55-80 Years: Effect on Body Composition, Libido, and Physical and Sexual Functioning
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
Read the detailed description
Background - In the context of hypogonadism, androgen supplementation is clearly beneficial, particularly in younger males. The benefits of therapy in men with milder degrees of hypogonadism, and elderly males with testosterone deficiency, are less clear-cut. Several options are available for androgen replacement in adult men. Oral testosterone, intramuscular injections, subcutaneous implants and transdermal therapy have all been used. Each mode of delivery has advantages and drawbacks. Several alkylated derivatives of T are available for oral or sublingual use, including methyl testosterone and fluoxymesterone. However, they are not recommended for use as replacement therapy because of their associated adverse effects.
Study Design - This is a multi-center, double-blind, placebo-controlled, parallel group, randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism. Total enrollment for this study will be approximately 120 subjects (40 subjects for each treatment group). Subjects will be treated with 35 mg/day DHT, 70 mg/day DHT, or placebo gel for 6 months. All subjects will apply the gel once daily. Up to 9 months of study participation, including up to 2 months of screening and a 1-month follow-up period, will be required by the protocol.
The primary efficacy endpoint in this study is change in body composition as determined by DEXA scan. Secondary endpoints in this study include change in sexual libido, and overall function and mood, and normalization of serum androgen levels. A subset of sites will perform strength assessments, which will include handgrip dynamometry, and upper and lower body strength tests.
- Conditions
- Hypogonadism, Late Onset Hypogonadism, Low Testosterone
- Being tested
- Dihydrotestosterone (0.7%) in hydroalcoholic gel
- Keywords
- libido, depression strength, testosterone, dihydrotestosterone
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo gel | Placebo comparator | Placebo gel twice per day Receives: 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 Receives: 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 Receives: Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Composition
Secondary outcomes (2)
Change in sexual libido, and overall function and mood
Normalization of serum androgen levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2006
- Study completion25 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASCEND Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neta R Nelson, Study director, ASCEND Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163566
- Sponsor's protocol ID
- 03-DHT-01
- Status last verified
- Aug 2022
- First submitted
- 9 Sep 2005
- Last updated
- 15 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Placebo-Controlled, Double-Blind, Dose-Ranging (35mg/Day or 70 mg/Day), Randomized, Study of Cutaneous Dihydrotestosterone (DHT)-Gel (0.7% Hydroalcoholic Gel) in Older Hypogonadal Males Ages 55-80 Years: Effect on Body Composition, Libido, and Physical and Sexual Functioning
- ClinicalTrials.gov ID
- NCT00163566
- Acronym / sponsor ID
- 03-DHT-01
- Conditions
- Hypogonadism, Late Onset Hypogonadism, Low Testosterone
- Keywords
- libido, depression strength, testosterone, dihydrotestosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- ASCEND TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- 25 Sep 2006 (actual)
- First posted
- 14 Sep 2005 (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.
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
Detailed description
Background - In the context of hypogonadism, androgen supplementation is clearly beneficial, particularly in younger males. The benefits of therapy in men with milder degrees of hypogonadism, and elderly males with testosterone deficiency, are less clear-cut. Several options are available for androgen replacement in adult men. Oral testosterone, intramuscular injections, subcutaneous implants and transdermal therapy have all been used. Each mode of delivery has advantages and drawbacks. Several alkylated derivatives of T are available for oral or sublingual use, including methyl testosterone and fluoxymesterone. However, they are not recommended for use as replacement therapy because of their associated adverse effects.
Study Design - This is a multi-center, double-blind, placebo-controlled, parallel group, randomized study of DHT-Gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism. Total enrollment for this study will be approximately 120 subjects (40 subjects for each treatment group). Subjects will be treated with 35 mg/day DHT, 70 mg/day DHT, or placebo gel for 6 months. All subjects will apply the gel once daily. Up to 9 months of study participation, including up to 2 months of screening and a 1-month follow-up period, will be required by the protocol.
The primary efficacy endpoint in this study is change in body composition as determined by DEXA scan. Secondary endpoints in this study include change in sexual libido, and overall function and mood, and normalization of serum androgen levels. A subset of sites will perform strength assessments, which will include handgrip dynamometry, and upper and lower body strength tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo gel | Placebo comparator | Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gelPlacebo gel twice per day |
| 0.7% DHT gel, Dose 1 | Active comparator | Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel0.7% DHT gel twice per day, 35 mg/day |
| 0.7% DHT gel, Dose 2 | Active comparator | Drug: Dihydrotestosterone (0.7%) in hydroalcoholic gel0.7% DHT gel twice per day, 70 mg/day |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men aged 55-80 Serum Testosterone < 275 Symptoms of Hypogonadism as determined by AMS scale In good overall health
Key exclusion criteria (1 listed)
- Abnormal Prostate Exam for age Prostate or Breast Cancer Significant illness Weight >300lbs Generalized skin disease Unstable sleep apnea
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 |
|---|---|---|
| Dihydrotestosterone (0.7%) in hydroalcoholic geltransdermal gel, 0.7% DHT, 0.35 mg/day or 0.70 mg/day total daily dose (or placebo gel), applied twice per day | Drug | 0.7% DHT gel, Dose 1, 0.7% DHT gel, Dose 2, Placebo gel |
Primary outcome
Change in Body Composition
2 secondary outcomes
Change in sexual libido, and overall function and mood
Normalization of serum androgen levels
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 15 Aug 2022.
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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.
Neta R Nelson study director
ASCEND Therapeutics
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dihydrotestosterone (0.7%) in hydroalcoholic gel in people with Hypogonadism and Late Onset Hypogonadism, run by ASCEND Therapeutics at 16 sites 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 1 inclusion and 1 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in Body Composition. 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 15 Aug 2022.