CompletedNCT00560833Updated Apr 2, 2019Results posted

Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)

A Phase 3 interventional study of esmirtazapine and Placebo in Menopause and Vasomotor Symptoms, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 3 years 1 month after the study started (first participant enrolled Oct 2004, registered Nov 2007).

Phase: Phase 3
Study type: Interventional
Enrollment: 943
Allocation: Randomized
Ages: 40 Years to 65 Years
Sex: Female

Study summary

The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary study hypothesis was that esmirtazapine would show superior efficacy to placebo.

Conditions studied

Menopause
Vasomotor Symptoms

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,160 studies on the registry; 134 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 65 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

postmenopausal women, defined as:
12 months of spontaneous amenorrhea;
OR 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone

(FSH) levels >40 mIU/mL;

OR 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
In case the menopausal status of a subject was unclear because of a hysterectomy, the serum FSH level had to be >40 mIU/mL. If the date of the last menstruation was not clear because of perimenopausal hormone use, then the subject had to have a serum FSH level >40 mIU/mL after completion of a washout period (see exclusion criteria below); be >= 40 and \<= 65 years of age;
have a body mass index (BMI) >= 18 and \<= 32 kg/m\^2;
minimum of 7 moderate to severe hot flushes per day or 50 per week, as quantified from daily diary recordings during at least 7 days preceding randomization to trial medication;
able to handle the electronic diary device after training and having at least 80% compliance on complete daily diary entries during the period prior to randomization;
give voluntary written Informed Consent (IC) after the scope and nature of the investigation had been explained, before screening evaluations.

Exclusion criteria

Exclusion Criteria:

history or presence of any malignancy, except non-melanoma skin cancers
any clinically unstable or uncontrolled renal, hepatic, endocrine,

respiratory, hematological, neurological, cardiovascular, or cerebrovascular disease that would put the subject at safety risk or mask measure of efficacy

history of seizures or epilepsy; history or presence of clinically significant depression or other psychiatric disorder which, in the opinion of the investigator, might compromise or confound the participant's participation in the trial; abnormal clinically relevant vaginal bleeding
any clinically relevant (opinion of investigator) abnormal finding during physical, gynecological and breast examination at screening; abnormal, clinically significant results of mammography. Mammography had to have been performed within the last 9 months prior to screening, otherwise it had to be done before inclusion into the trial. For non-US sites, if local laws or guidelines did not allow or advise such frequent mammograms, the documented local laws or guidelines were to be followed; abnormal cervical smear test results (corresponding to Pap III and higher, including Low-Grade Squamous Intraepithelial Lesion (LSIL), High-Grade Squamous Intraepithelial Lesion (HSIL), Cervical Intraepithelial Neoplasia (CIN) 1 and higher). A cervical smear had to have been performed within the last 9 months prior to screening, otherwise it had to be done before inclusion into the trial; hematological or biochemical values at screening outside the reference ranges considered clinically relevant in the opinion of the investigator
high blood pressure (BP) (sitting systolic BP >170 mmHg and/or diastolic BP >100 mmHg)
use of any drug product containing estrogens, progestins, androgens, or tibolone prior to screening (and up to and including randomization) within specified time frames

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 943 participants (actual)

Study arms

Placebo comparator
Placebo
Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
Drug: Placebo
Experimental
Esmirtazapine 2.25 mg
Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
Drug: esmirtazapine
Experimental
Esmirtazapine 4.5 mg
Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
Drug: esmirtazapine
Experimental
Esmirtazapine 9 mg
Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
Drug: esmirtazapine
Experimental
Esmirtazapine 18 mg
Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
Drug: esmirtazapine

Interventions

Drugesmirtazapine
Also known as: Esmirtazapine maleate, SCH 900265, Org 50081
DrugPlacebo

What researchers measure

Primary outcomes

Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4
Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.
Time frame: Baseline and Week 4
Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12
Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.
Time frame: Baseline and Week 12
Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.
Time frame: Baseline and Week 4
Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12
Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.
Time frame: Baseline and Week 12

Secondary outcomes

Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12
The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.
Time frame: Baseline and Week 12

Results

Posted Jun 30, 2014

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Started	317	155	160	155	156
Treated	317	154	160	155	155
Completed	273	129	121	124	114
Not completed	44	26	39	31	42
Withdrew: Adverse event	16	10	25	23	35
Withdrew: Lost to follow-up	0	0	1	0	0
Withdrew: Lack of efficacy	22	9	6	4	4
Withdrew: Participant uncooperative	5	5	4	4	2
Withdrew: Other	1	1	3	0	0
Withdrew: Never received drug	0	1	0	0	1

Outcome measures

PrimaryChange From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4

Participants recorded the frequency of vasomotor symptoms (hot flushes) on an electronic diary card (LogPad®) on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.

Time frame:: Baseline and Week 4
Reported as:: Mean · Number of events

Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4
Number of events	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 4	-3.9 ± 4.2	-5.6 ± 3.8	-6.0 ± 3.6	-6.0 ± 4.0	-6.0 ± 4.4

Statistical analysis

Placebo vs Esmirtazapine 2.25 mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -1.4 · 95% CI -2.3 to -0.4
Placebo vs Esmirtazapine 4.5 mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -2.2 · 95% CI -3.1 to -1.2
Placebo vs Esmirtazapine 9 mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -1.9 · 95% CI -2.9 to -1.0
Placebo vs Esmirtazapine 18mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -1.9 · 95% CI -2.9 to -1.0

SecondaryChange From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12

The WHQ is a 36-item, user-friendly, and rapid way of assessing nine domains of physical and emotional health for mid-aged women. Participants self-administered the WHQ questionnaire; scoring is based on a 4-point scale as follows: 'Yes definitely=1', 'Yes sometimes=2', 'No not much=3' and 'No not at all=4'. Each score is transformed to a value '1' for scores '1' and '2' and to a value '0' for scores '3' and '4'. Vasomotor symptoms encompass Items 19 and 27 of the 36 total items. The transformed sums of items 19+27 are divided by 2 to get the score; therefore, the domain ranges from 0 to 1, where lower values are better.

Time frame:: Baseline and Week 12
Reported as:: Mean · Score on a scale

Change From Baseline in Vasomotor Symptoms Score Per Women's Health Questionnaire (WHQ) at Week 12
Score on a scale	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Baseline	0.984 ± 0.088	0.993 ± 0.060	0.985 ± 0.085	0.981 ± 0.114	0.985 ± 0.085
Change from baseline	-0.151 ± 0.329	-0.235 ± 0.355	-0.256 ± 0.355	-0.256 ± 0.372	-0.246 ± 0.385

PrimaryChange From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12

Participants recorded the frequency of vasomotor symptoms (hot flushes) on a LogPad on a daily basis during screening and treatment. Frequency score A was based on the number of moderate hot flushes + the number of severe hot flushes in one day. Baseline average was derived from, at most, 7 completely observed pre-treatment days. Weekly averages during treatment were calculated if at least 4 days with non-missing data were completely observed; if less than 4 days were completely observed, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.

Time frame:: Baseline and Week 12
Reported as:: Mean · number of events

Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12
number of events	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Change From Baseline in Average Daily Frequency of Vasomotor Symptoms (Frequency Score A) at Week 12	-4.9 ± 4.8	-6.2 ± 5.1	-6.7 ± 3.9	-6.9 ± 4.4	-6.5 ± 4.4

Statistical analysis

Placebo vs Esmirtazapine 2.25 mg · ANCOVA · p = 0.06 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -1.0 · 95% CI -2.0 to 0.0
Placebo vs Esmirtazapine 4.5 mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -2.0 · 95% CI -3.0 to -0.9
Placebo vs Esmirtazapine 9 mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -1.9 · 95% CI -2.9 to -0.9
Placebo vs Esmirtazapine 18mg · ANCOVA · p = <0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -1.5 · 95% CI -2.6 to -0.5

PrimaryChange From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4

Participants recorded the severity of hot flushes on a LogPad on a daily basis during screening and treatment. The severity of hot flushes was defined as: mild (sensation of heat without sweating); moderate (sensation of heat with sweating, able to continue activity); and severe (sensation of heat with sweating, causing cessation of activity). Severity score A was calculated as the number of moderate hot flushes x 2 + the number of severe hot flushes x 3, divided by the total number of moderate and severe hot flushes. If no hot flushes were experienced, this was to be recorded as 'no sensation of heat'. Baseline values were based on, at most, 7 completely observed pre-treatment days. If less than 4 days were completely observed during treatment, the averages of the previous week were carried forward (last observation carried forward, or LOCF). If the number of days observed in Week 1 were not sufficient, baseline values were carried forward.

Time frame:: Baseline and Week 4
Reported as:: Mean · score on a scale

Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4
score on a scale	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 4	-0.09 ± 0.23	-0.11 ± 0.22	-0.15 ± 0.25	-0.16 ± 0.24	-0.15 ± 0.24

Statistical analysis

Placebo vs Esmirtazapine 2.25 mg · ANCOVA · p = 0.62 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.03 · 95% CI -0.09 to 0.03
Placebo vs Esmirtazapine 4.5 mg · ANCOVA · p = 0.02 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.06 · 95% CI -0.12 to -0.01
Placebo vs Esmirtazapine 9 mg · ANCOVA · p = 0.01 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.07 · 95% CI -0.13 to -0.01
Placebo vs Esmirtazapine 18mg · ANCOVA · p = 0.02 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.06 · 95% CI -0.12 to -0.01

PrimaryChange From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12

Time frame:: Baseline and Week 12
Reported as:: Mean · score on a scale

Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12
score on a scale	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Change From Baseline in Average Daily Severity of Moderate/Severe Vasomotor Symptoms (Severity Score A) at Week 12	-0.12 ± 0.28	-0.10 ± 0.27	-0.15 ± 0.29	-0.18 ± 0.26	-0.17 ± 0.26

Statistical analysis

Placebo vs Esmirtazapine 2.25 mg · ANCOVA · p = 1.0 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): 0.01 · 95% CI -0.06 to 0.07
Placebo vs Esmirtazapine 4.5 mg · ANCOVA · p = 0.72 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.03 · 95% CI -0.09 to 0.04
Placebo vs Esmirtazapine 9 mg · ANCOVA · p = 0.13 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.06 · 95% CI -0.12 to 0.01
Placebo vs Esmirtazapine 18mg · ANCOVA · p = 0.15 (Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.) · Mean difference (final values): -0.05 · 95% CI -0.12 to 0.01

Adverse events

Collected over Non-serious adverse events were collected up to 7 days after the last dose of study drug; serious adverse events were collected for up to 30 days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	2/317 (0.6%)	128/317 (40.4%)
Esmirtazapine 2.25 mg	—	1/154 (0.6%)	93/154 (60.4%)
Esmirtazapine 4.5 mg	—	3/160 (1.9%)	99/160 (61.9%)
Esmirtazapine 9 mg	—	2/155 (1.3%)	102/155 (65.8%)
Esmirtazapine 18mg	—	0/155 (0%)	123/155 (79.4%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
Appendicitis perforatedGastrointestinal disorders	0/317	1/154	0/160	0/155	0/155
Oedema peripheralGeneral disorders	0/317	0/154	0/160	1/155	0/155
Vaginal lesionReproductive system and breast disorders	0/317	0/154	0/160	1/155	0/155
Large intestine perforationGastrointestinal disorders	0/317	0/154	1/160	0/155	0/155
Diabetic ketoacidosisMetabolism and nutrition disorders	0/317	0/154	1/160	0/155	0/155
Conversion disorderPsychiatric disorders	0/317	0/154	1/160	0/155	0/155
PyelonephritisInfections and infestations	1/317	0/154	0/160	0/155	0/155
ScarSkin and subcutaneous tissue disorders	1/317	0/154	0/160	0/155	0/155

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmirtazapine 18mg
SomnolenceNervous system disorders	19/317	33/154	37/160	44/155	50/155
Weight increasedInvestigations	18/317	25/154	24/160	32/155	45/155
Increased appetiteMetabolism and nutrition disorders	13/317	12/154	21/160	14/155	28/155
HeadacheNervous system disorders	54/317	11/154	13/160	14/155	19/155
Dry mouthGastrointestinal disorders	6/317	9/154	7/160	18/155	22/155
FatigueGeneral disorders	11/317	19/154	19/160	19/155	20/155
ArthralgiaMusculoskeletal and connective tissue disorders	16/317	5/154	9/160	14/155	5/155
DizzinessNervous system disorders	12/317	6/154	12/160	6/155	14/155
LethargyNervous system disorders	1/317	7/154	14/160	5/155	4/155
InsomniaPsychiatric disorders	13/317	6/154	10/160	6/155	13/155

Baseline characteristics

All participants who received any study drug (placebo or esmertazapine), whether or not randomized.

Age, Continuous
Age, Continuous(Years)	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmertazapine 18 mg	Total
Mean	54.0 ± 4.4	53.4 ± 4.4	54.1 ± 4.2	54.9 ± 4.8	54.1 ± 4.5	54.1 ± 4.4

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Esmirtazapine 2.25 mg	Esmirtazapine 4.5 mg	Esmirtazapine 9 mg	Esmertazapine 18 mg	Total
Female	317	154	160	155	155	941
Male	0	0	0	0	0	0

Study locations

No study locations are listed for this record.

References and documents

Publications

Birkhaeuser M, Bitzer J, Braat S, Ramos Y. Esmirtazapine treatment of postmenopausal vasomotor symptoms: two randomized controlled trials. Climacteric. 2019 Jun;22(3):312-322. doi: 10.1080/13697137.2018.1561664. Epub 2019 Feb 4. PubMed 30712391 ↗

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · engagezone.msd.com

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00560833
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Nov 20, 2007
Start date: Oct 15, 2004
Primary completion: Jan 15, 2006
Completion: Jan 15, 2006
Results posted: Jun 30, 2014
Last update: Apr 2, 2019

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)

From the registry’s dates

Study summary

Conditions studied

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Individual participant data

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria