PostmenopausePhase 1NCT00799708
A Study of the Effect of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women (0000-094)(COMPLETED)
A Phase 1 study testing Comparator: Estrace in people with Postmenopause, run by Merck Sharp & Dohme LLC.
Trial summary
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause
- What is being tested?
- Comparator: Estrace
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is healthy, postmenopausal woman at least 40 years of age with onset of menopause within 10 years of screening
- Subject has a normal mammogram at screening
- Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not had a Pap-smear in the last 3 years will have the option to have the test at screening
- Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva flow
- Subject is willing to avoid strenuous exercise during the study
- Subject is willing to avoid use of mouthwash or salt water rinses during the study
Show all 11Show fewer
- Subject is willing to avoid use of teeth whitening products
- Subject is willing to avoid eating and/or drinking grapefruit products
- Subject is willing to limit alcohol consumption to 2 drinks a day
- Subject is willing to limit caffeine consumption to 3 cups of coffee (or equivalent) per day
- Subject is a non-smoker
Who cannot join
- Subject has a history of multiple and/or severe allergies to drugs or food
- Subject has a cold or viral infection within 2 weeks of Visit 2
- Subject is taking antibiotics within 2 weeks of Visit 2
- Subject needs dental work or procedures during the study
- Subject has used any estrogen or progesterone preparation or product containing phytoestrogens within 3 months of screening
- Subject is unable to discontinue anti-coagulants
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
- Conditions
- Postmenopause
- Being tested
- Comparator: placebo, Comparator: Estrace
- Keywords
- Biomarkers of estrogen receptor beta activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: placeboDrug
placebo capsule once daily for 7 days.
Comparator: EstraceDrug
Also called Estrace
Estrace 0.5 mg or 2 mg tablets once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Comparator: placebo |
| 2 | Active comparator | Estrace 0.5 mg Receives: Drug: Comparator: Estrace |
| 3 | Active comparator | Estrace 2 mg Receives: Drug: Comparator: Estrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7
Subset of genes on the log ratio intensity scale from a microarray platform - signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens- quantified as a ratio of up regulated versus down regulated genes
Measured: Baseline and Day 7
Secondary outcomes (1)
Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.
Change from baseline in unstimulated labial gland saliva flow rate at Day 7
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PostmenopauseStudies 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
- 27 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
- NCT00799708
- Sponsor's protocol ID
- 0000-094
- Other IDs
- 094, 2008_592
- Status last verified
- Feb 2016
- First submitted
- 26 Nov 2008
- Last updated
- 16 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00799708
- Acronym / sponsor ID
- 0000-094
- Conditions
- Postmenopause
- Keywords
- Biomarkers of estrogen receptor beta activation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Posted 29 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Comparator: placeboPlacebo |
| 2 | Active comparator | Drug: Comparator: EstraceEstrace 0.5 mg |
| 3 | Active comparator | Drug: Comparator: EstraceEstrace 2 mg |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is healthy, postmenopausal woman at least 40 years of age with onset of menopause within 10 years of screening
- Subject has a normal mammogram at screening
- Subject has had a normal Pap-smear within 3 years of screening. Subjects who have not had a Pap-smear in the last 3 years will have the option to have the test at screening
- Subject agrees to avoid medications that cause dry mouth or otherwise affect saliva flow
- Subject is willing to avoid strenuous exercise during the study
Key exclusion criteria (6 listed)
- Subject has a history of multiple and/or severe allergies to drugs or food
- Subject has a cold or viral infection within 2 weeks of Visit 2
- Subject is taking antibiotics within 2 weeks of Visit 2
- Subject needs dental work or procedures during the study
- Subject has used any estrogen or progesterone preparation or product containing phytoestrogens within 3 months of screening
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 |
|---|---|---|
| Comparator: placeboplacebo capsule once daily for 7 days. | Drug | 1 |
| Comparator: EstraceAlso: EstraceEstrace 0.5 mg or 2 mg tablets once daily for 7 days. | Drug | 2, 3 |
Primary outcome
Change From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7
Time frame: Baseline and Day 7
Subset of genes on the log ratio intensity scale from a microarray platform - signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens- quantified as a ratio of up regulated versus down regulated genes
1 secondary outcome
Change From Baseline in Minor Gland Salivary Flow Rate After Treatment With 2 mg Estradiol vs Placebo at Day 7.
Time frame: Baseline and Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: Estrace in people with Postmenopause, 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 11 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 16 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in Estrogen Receptor Beta (ERbeta) -Specific Gene Signature After Treatment With 2 mg, 0.5 mg, or no Estradiol (Placebo) at Day 7 (time frame: Baseline and Day 7). 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 16 Mar 2016.