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Completed

NCT Number: NCT00272935

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

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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Huntsville, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cenestin 0.3 mg Tablets

Drug

1 tablet daily

Other names: Synthetic conjugated estrogens, A

Placebo

Other

1 tablet daily

Other names: Placebo tablets

Primary outcomes

  1. Mean change in average frequency of moderate to severe hot flashes

    Time frame: Baseline to Day 28 and to Day 84

  2. Mean change in severity of moderate to severe hot flashes

    Time frame: Baseline to Day 28 and to Day 84

Secondary outcomes

  1. Safety and tolerability of Cenestin 0.3mg

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 9, 2006
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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