Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

Duramed Research

Status and phase: Completed; Phase 4

Conditions: Nocturnal Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: SCE-B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00592839

DR-ENJ-401

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Naturally or surgically menopausal
• Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion criteria

• Any contraindication to hormone therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

0.3 mg SCE-B Daily

Treatment:

Drug: Placebo

Drug: SCE-B

2

Experimental group

Description:

0.625 mg SCE-B Daily

Treatment:

Drug: Placebo

Drug: SCE-B

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo