A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes - Full Text View

Sponsor:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00272935

Purpose

This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.

Condition	Intervention	Phase
Hot Flashes	Drug: Cenestin 0.3 mg Tablets Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women

Resource links provided by NLM:

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

Further study details as provided by Duramed Research:

Primary Outcome Measures:

Mean change in average frequency of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ] [ Designated as safety issue: No ]
Mean change in severity of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of Cenestin 0.3mg [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	December 2005
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Cenestin 0.3 mg Tablets 1 tablet daily
2: Placebo Comparator	Other: Placebo 1 tablet daily

Detailed Description:

The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Naturally or surgically postmenopausal
At least 12 months since last menses or 6 weeks past surgery
Minimum of 7 daily or 50 weekly moderate to severe hot flashes

Exclusion Criteria:

Any contraindication to natural or synthetic estrogens

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272935

Show 49 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duramed Research Protocol Chair

Duramed Research, Inc

More Information

Additional Information:

NIH - Postmenopausal Hormone Therapy This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Duramed Research, Inc. ( Duramed Protocol Chair )
Study ID Numbers:	BR-CEN-301
Study First Received:	January 4, 2006
Last Updated:	January 8, 2010
ClinicalTrials.gov Identifier:	NCT00272935 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

menopause
vasomotor symptoms

Additional relevant MeSH terms:

Signs and Symptoms
Estrogens, conjugated synthetic A
Estrogens
Estrogens, Conjugated (USP)
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hot Flashes
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010