Conditions: Nocturnal Vasomotor Symptoms
Keywords: Nocturnal vasomotor symptoms in postmenopausal women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 157
Healthy volunteers: yes

Brief summary:
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.

Detailed description:

Arms:
arm 1: 0.3 mg SCE-B Daily arm 2: 0.625 mg SCE-B Daily arm 3: Placebo

Interventions: intervention 1: SCE-B intervention 2: Placebo
Intervention descriptions: intervention 1: 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo intervention 2: Matching placebo for 0.3 mg and 0.625 mg tablets

Protocol document: