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

Completed · Phase 4 · Has a placebo group

Conditions studied: Nocturnal Vasomotor Symptoms

In brief

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.

Key facts

Study ID

NCT00592839

Run by

Duramed Research

People needed

157

Starts

2007-12-01

Expected to finish

2009-02-01

Last updated by the study team

2013-07-19

Who can join

Age: 30 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Any contraindication to hormone therapy

Where it is running

• Duramed Investigational Site — Anaheim, California, United States
• Duramed Investigational Site — Sacramento, California, United States
• Duramed Investigational Site — San Diego, California, United States
• Duramed Investigational Site — Clearwater, Florida, United States
• Duramed Investigational Site — West Palm Beach, Florida, United States
• Duramed Investigational Site — Lexington, Kentucky, United States
• Duramed Investigational Site — Louisville, Kentucky, United States
• Duramed Investigational Site — Lincoln, Nebraska, United States
• Duramed Investigational Site — Moorestown, New Jersey, United States
• Duramed Investigational Site — Albuquerque, New Mexico, United States
• Duramed Investigational Site — Winston-Salem, North Carolina, United States
• Duramed Investigational Site — Cleveland, Ohio, United States
• Duramed Investigational Site — Mayfield Heights, Ohio, United States
• Duramed Investigational Site — Medford, Oregon, United States
• Duramed Investigational Site — Pittsburgh, Pennsylvania, United States
• Duramed Investigational Site — Columbia, South Carolina, United States
• Duramed Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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