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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:


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 ] [ 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
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
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014