Postmenopausal SymptomsPhase 1NCT00820664
A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
A Phase 1 study testing Comparator: Estrace 0.5 mg and Comparator: Estrace 2 mg in people with Postmenopausal Symptoms, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Comparator: Estrace 0.5 mg and Comparator: Estrace 2 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to May 2009
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is a healthy postmenopausal woman less than or equal to 65 years of age with onset of menopause less than or equal to 10 years prior to prestudy visit 1
- Patient has a uterus and no history of uterine bleeding in the past 3 months
- Patient has not had a previous endometrial biopsy within the last 4 weeks
- Patient has had a normal mammogram within the last 11 months
- Patient has had a normal pap-smear within the past 3 years prior to screening
- Patient has had a normal transvaginal ultrasound of the endometrium
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- Patient is willing to avoid strenuous physical activity such as strenuous or unaccustomed weight lifting, running, bicycling, etc for the duration of the study
- Patient agrees to not consume grapefruit products beginning approximately 2 weeks prior to the first dose of study drug and throughout the study
- Patient agrees to limit daily consumption of alcohol. During the study, daily alcohol consumption should not be more than 2 glasses
- Patient agrees to limit daily consumption of caffeine. During the study, daily caffeine consumption should not exceed 3 cups of coffee
- Patient is a non-smoker
Who cannot join
- Patient is mentally or legally incapacitated
- Patient has a history of any first degree relatives with breast or endometrial cancer
- Patient has a history of multiple and/or severe allergies to prescription or non-prescription drugs or food
- Patient has used any type of estrogen or progesterone preparation unless followed by appropriate wash-out periods
- Patient has had surgery, donated approximately 500 mL of blood or has participated in another investigational study within the last 4 weeks
- Patient has a history of deep vein thromboses, coronary artery disease, heart attack or stroke
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- Patient is a current user of illegal drugs
- Patient has a history of hypersensitivity to estrogen products
- Patient is unable to refrain from using anti-coagulants
About this study
Official title: A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women
The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium).
- Conditions
- Postmenopausal Symptoms
- Being tested
- Comparator: Estrace 0.5 mg, Comparator: Estrace 2 mg, Comparator: Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: Estrace 0.5 mgDrug
Also called Estrace
0.5 mg tablet taken once daily for 28 days
Comparator: Estrace 2 mgDrug
Also called Estrace
2 mg tablets taken once daily for 28 days.
Comparator: PlaceboDrug
Placebo 0 mg capsule taken once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 17β-estradiol 2.0 milligrams | Active comparator | Estrace 2.0 mg tablet Receives: Drug: Comparator: Estrace 2 mg |
| 17β-estradiol 0.5 milligrams | Active comparator | Estrace 0.5 mg tablet Receives: Drug: Comparator: Estrace 0.5 mg |
| 3 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemistry (IHC) Proliferative Effects Measurement
Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.
Measured: 4 weeks
Secondary outcomes (1)
Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2009
- Study completionMay 2009
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 Postmenopausal SymptomsStudies 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
- 29 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
- NCT00820664
- Sponsor's protocol ID
- 0000-122
- Other IDs
- 2009_505
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2009
- Last updated
- 22 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00820664
- Acronym / sponsor ID
- 0000-122
- Conditions
- Postmenopausal Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Posted 7 May 2010
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 examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 17β-estradiol 2.0 milligrams | Active comparator | Drug: Comparator: Estrace 2 mgEstrace 2.0 mg tablet |
| 17β-estradiol 0.5 milligrams | Active comparator | Drug: Comparator: Estrace 0.5 mgEstrace 0.5 mg tablet |
| 3 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is a healthy postmenopausal woman less than or equal to 65 years of age with onset of menopause less than or equal to 10 years prior to prestudy visit 1
- Patient has a uterus and no history of uterine bleeding in the past 3 months
- Patient has not had a previous endometrial biopsy within the last 4 weeks
- Patient has had a normal mammogram within the last 11 months
- Patient has had a normal pap-smear within the past 3 years prior to screening
Key exclusion criteria (9 listed)
- Patient is mentally or legally incapacitated
- Patient has a history of any first degree relatives with breast or endometrial cancer
- Patient has a history of multiple and/or severe allergies to prescription or non-prescription drugs or food
- Patient has used any type of estrogen or progesterone preparation unless followed by appropriate wash-out periods
- Patient has had surgery, donated approximately 500 mL of blood or has participated in another investigational study within the last 4 weeks
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: Estrace 0.5 mgAlso: Estrace0.5 mg tablet taken once daily for 28 days | Drug | 17β-estradiol 0.5 milligrams |
| Comparator: Estrace 2 mgAlso: Estrace2 mg tablets taken once daily for 28 days. | Drug | 17β-estradiol 2.0 milligrams |
| Comparator: PlaceboPlacebo 0 mg capsule taken once daily for 28 days | Drug | 3 |
Primary outcome
Immunohistochemistry (IHC) Proliferative Effects Measurement
Time frame: 4 weeks
Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.
1 secondary outcome
Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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 0.5 mg and Comparator: Estrace 2 mg in people with Postmenopausal Symptoms, 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 9 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 22 Jan 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 7 May 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?
Immunohistochemistry (IHC) Proliferative Effects Measurement (time frame: 4 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 22 Jan 2016.