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

This study has been completed.

Sponsor:

Information provided by:

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00272935

First received: January 4, 2006

Last updated: June 29, 2012

Last verified: July 2009

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
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 Teva Pharmaceutical Industries:

Primary Outcome Measures:

Mean change in average frequency of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ]
Mean change in severity of moderate to severe hot flashes [ Time Frame: Baseline to Day 28 and to Day 84 ]

Secondary Outcome Measures:

Safety and tolerability of Cenestin 0.3mg [ Time Frame: Throughout study ]


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
Experimental: 1	Drug: Cenestin 0.3 mg Tablets 1 tablet daily Other Name: Synthetic conjugated estrogens, A
Placebo Comparator: 2	Other: Placebo 1 tablet daily Other Name: Placebo tablets

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 (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier:	NCT00272935 History of Changes
Other Study ID Numbers:	BR-CEN-301
Study First Received:	January 4, 2006
Last Updated:	June 29, 2012

Keywords provided by Teva Pharmaceutical Industries:


menopause vasomotor symptoms

Additional relevant MeSH terms:


Hot Flashes Signs and Symptoms Estrogens Estrogens, Conjugated (USP)	Estrogens, conjugated synthetic A Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017

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