NCT00535288View on ClinicalTrials.gov

Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013)

PHASE3CompletedINTERVENTIONAL
Enrollment

946

Participants

Timeline

Start Date

September 15, 2004

Primary Completion Date

January 15, 2006

Study Completion Date

January 15, 2006

Conditions
Postmenopausal SymptomsMenopauseVasomotor Symptoms
Interventions
DRUG

Esmirtazapine

Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.

DRUG

Placebo

Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00535288 - Dose-Finding Safety and Efficacy Trial of Org 50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (177001/P06472/MK-8265-013) | Biotech Hunter | Biotech Hunter