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| ID | Type | Description | Link |
|---|---|---|---|
| 094 | |||
| 2008_592 |
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This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Active Comparator | Estrace 0.5 mg |
|
| 3 | Active Comparator | Estrace 2 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: placebo | Drug | placebo capsule once daily for 7 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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This was a randomized, double-blind, placebo-controlled parallel group study in healthy postmenopausal women. Enrollment occurred from May 2008 through October 2008 across two US Phase I clinical research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 17β-estradiol 2.0 Milligrams | Estrace 2 mg tablets once daily for 7 days. |
| FG001 | 17β-estradiol 0.5 Milligrams | Estrace 0.5 mg tablets once daily for 7 days. |
| FG002 | Placebo | Placebo capsule once daily for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 17β-estradiol 2.0 Milligrams | Estrace 2 mg tablets once daily for 7 days. |
| BG001 | 17β-estradiol 0.5 Milligrams | Estrace 0.5 mg tablets once daily for 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All subjects with salivary gland tissue with RNA of acceptable quality based on pre-specified QC criteria | Posted | Least Squares Mean | Standard Error | Fold change | Baseline and Day 7 |
|
AEs were collected from the time the subject signed the consent form until 14 days following the last dose of study medication.
AEs were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (chemistry, hematology, urinalysis) and ECG at time points specified in the study. Subjects were queried at each visit for any clinical adverse experiences that may have occurred since the previous visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 17β-estradiol 2.0 Milligrams | Estrace 2 mg tablets once daily for 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Comparator: Estrace |
| Drug |
Estrace 0.5 mg or 2 mg tablets once daily for 7 days. |
|
|
| BG002 | Placebo | Placebo capsule once daily for 7 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Estrace 0.5 mg tablets once daily for 7 days. |
| OG002 | Placebo | Placebo capsule once daily for 7 days. |
|
|
|
| Secondary | 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 | All subjects with salivary flow rate measured at baseline and 7 days | Posted | Least Squares Mean | 90% Confidence Interval | μL/min | Baseline and Day 7 |
|
|
|
|
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | 17β-estradiol 0.5 Milligrams | Estrace 0.5 mg tablets once daily for 7 days. | 0 | 6 | 4 | 6 |
| EG002 | Placebo | Placebo capsule once daily for 7 days. | 0 | 11 | 7 | 11 |
| Abdominal Pain Lower | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Hypoaesthesia Oral | Gastrointestinal disorders | Systematic Assessment |
|
| Lip Disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Lip Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Lip Swelling | Gastrointestinal disorders | Systematic Assessment |
|
| Saliva Altered | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Oedema Peripheral | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural Site Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Burning Sensation | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Tongue Biting | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Adnexa Uteri Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Breast Tenderness | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Disorder | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Hot Flush | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |