Skin AndrogenizationPhase 1NCT00969163
A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).
A Phase 1 study testing testosterone gel in people with Skin Androgenization, run by Merck Sharp & Dohme LLC.
Trial summary
Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Androgenization
- What is being tested?
- testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2005
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is at least 3 years postmenopausal
- Subject is in good general health
- Subject is willing to avoid excess alcohol or strenuous physical activity during the study
Who cannot join
- Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
- Subject is a regular user of any illicit drugs
- Subject drinks excessive amounts of coffee, tea or cola
- Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
- Subject has a history of cancer
- Subject has acne
About this study
Official title: A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women
Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.
- Conditions
- Skin Androgenization
- Being tested
- testosterone gel, Comparator: placebo
- Keywords
- Biomarkers of Skin Androgenization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone gelDrug
Also called AndroGel
300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
Comparator: placeboDrug
transdermal placebo gel for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2.5 mg testosterone gel Receives: Drug: testosterone gel |
| 2 | Experimental | 300 ug testosterone gel Receives: Drug: testosterone gel |
| 3 | Placebo comparator | placebo gel Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum free testosterone concentrations following multiple doses of AndroGel
Measured: 6 weeks
Secondary outcomes (1)
mean percent change from baseline in sebum excretion
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startOct 2004
- Primary completionApr 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AndrogenizationStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969163
- Sponsor's protocol ID
- 0000-015
- Other IDs
- MK0000-015, 2009_654
- Status last verified
- Sep 2014
- First submitted
- 31 Aug 2009
- Last updated
- 4 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00969163
- Acronym / sponsor ID
- 0000-015
- Conditions
- Skin Androgenization
- Keywords
- Biomarkers of Skin Androgenization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 1 Sep 2009 (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.
Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: testosterone gel2.5 mg testosterone gel |
| 2 | Experimental | Drug: testosterone gel300 ug testosterone gel |
| 3 | Placebo comparator | Drug: Comparator: placeboplacebo gel |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is at least 3 years postmenopausal
- Subject is in good general health
- Subject is willing to avoid excess alcohol or strenuous physical activity during the study
Key exclusion criteria (6 listed)
- Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
- Subject is a regular user of any illicit drugs
- Subject drinks excessive amounts of coffee, tea or cola
- Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
- Subject has a history of cancer
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 |
|---|---|---|
| testosterone gelAlso: AndroGel300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks | Drug | 1, 2 |
| Comparator: placebotransdermal placebo gel for 6 weeks | Drug | 3 |
Primary outcome
serum free testosterone concentrations following multiple doses of AndroGel
Time frame: 6 weeks
1 secondary outcome
mean percent change from baseline in sebum excretion
Time frame: 6 weeks
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 4 Sep 2014.
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing testosterone gel in people with Skin Androgenization, run by Merck Sharp & Dohme LLC.
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 6 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 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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 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?
serum free testosterone concentrations following multiple doses of AndroGel (time frame: 6 weeks). 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 4 Sep 2014.