CClinicalTrials.gg
CompletedNCT00272935Updated Jul 3, 2012

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

A Phase 3 interventional study of Cenestin 0.3 mg Tablets and Placebo in Hot Flashes, sponsored by Duramed Research. Completed at 49 sites in United States. Open to female participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-07-03.

Sponsored by Duramed Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
Female
01

Study summary

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.

Read the 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

02

Conditions studied

  • Hot Flashes

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Keywords

  • menopause
  • vasomotor symptoms
03

In context

Hot Flashes

285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.

This study's planned enrollment of 400 is above the median of 90 across 255 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Duramed Research is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Any contraindication to natural or synthetic estrogens
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    1

    Drug: Cenestin 0.3 mg Tablets

  • Placebo comparator
    2

    Other: Placebo

Interventions

  • DrugCenestin 0.3 mg Tablets

    1 tablet daily

    Also known as: Synthetic conjugated estrogens, A

  • OtherPlacebo

    1 tablet daily

    Also known as: Placebo tablets

06

What researchers measure

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

07

Study locations

49 sites
  • Duramed Investigational Site
    Huntsville, Alabama 35801, United States
  • Duramed Investigational Site
    Montgomery, Alabama 36116, United States
  • Duramed Investigational Site
    Phoenix, Arizona 85013, United States
  • Duramed Investigational Site
    Phoenix, Arizona 85032, United States
  • Duramed Investigational Site
    Tucson, Arizona 85712, United States
  • Duramed Investigational Site
    Carmichael, California 95608, United States
  • Duramed Investigational Site
    Irvine, California 92618, United States
  • Duramed Investigational Site
    San Diego, California 72108, United States
  • Duramed Investigational Site
    San Diego, California 92103, United States
  • Duramed Investigational Site
    San Diego, California 92123, United States
  • Duramed Investigational Site
    San Ramon, California 94583, United States
  • Duramed Investigational Site
    Brooksville, Florida 34613, United States
  • Duramed Investigational Site
    Coral Gables, Florida 33134, United States
  • Duramed Investigational Site
    Gainesville, Florida 32607, United States
  • Duramed Investigational Site
    Leesburg, Florida 34748, United States
  • Duramed Investigational Site
    Miami, Florida 33143, United States
  • Duramed Investigational Site
    Palm Springs, Florida 33461, United States
  • Duramed Investigational Site
    Venice, Florida 34285, United States
  • Duramed Investigational Site
    Alpharetta, Georgia 30005, United States
  • Duramed Investigational Site
    Douglasville, Georgia 30134, United States
  • Duramed Investigational Site
    Boise, Idaho 83712, United States
  • Duramed Investigational Site
    Evansville, Indiana 47714, United States
  • Duramed Investigational Site
    Lexington, Kentucky 40509, United States
  • Duramed Investigational Site
    Baltimore, Maryland 21224, United States
  • Duramed Investigational Site
    Lincoln, Nebraska 68510, United States
  • Duramed Investigational Site
    Las Vegas, Nevada 89146, United States
  • Duramed Investigational Site
    Albuquerque, New Mexico 87102, United States
  • Duramed Investigational Site
    Cleveland, Ohio 44122, United States
  • Duramed Investigational Site
    Columbus, Ohio 43213, United States
  • Duramed Investigational Site
    Mayfield Heights, Ohio 44124, United States
  • Duramed Investigational Site
    Medford, Oregon 97504, United States
  • Duramed Investigational Site
    King of Prussia, Pennsylvania 19406, United States
  • Duramed Investigational Site
    North Wales, Pennsylvania 19454, United States
  • Duramed Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • Duramed Investigational Site
    Philadelphia, Pennsylvania 19114, United States
  • Duramed Investigational Site
    Pittsburgh, Pennsylvania 15206, United States
  • Duramed Investigational Site
    Charleston, South Carolina 29401, United States
  • Duramed Investigational Site
    Bristol, Tennessee 37620, United States
  • Duramed Investigational Site
    Clarksville, Tennessee 37043, United States
  • Duramed Investigational Site
    Nashville, Tennessee 37203, United States
  • Duramed Investigational Site
    Dallas, Texas 75390, United States
  • Duramed Investigational Site
    Fort Worth, Texas 76104, United States
  • Duramed Investigational Site
    Houston, Texas 77015, United States
  • Duramed Investigational Site
    Houston, Texas 77030, United States
  • Duramed Investigational Site
    Houston, Texas 77074, United States
  • Duramed Investigational Site
    San Antonio, Texas 78229, United States
  • Duramed Investigational Site
    Norfolk, Virginia 23507, United States
  • Duramed Investigational Site
    Spokane, Washington 92207, United States
  • Duramed Investigational Site
    Tacoma, Washington 98405, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00272935
Lead sponsor
Duramed Research
First posted
Jan 9, 2006
Start date
Dec 2005
Primary completion
May 2007
Completion
May 2007
Last update
Jul 3, 2012

Study contacts

Duramed Research Protocol Chair
study chair · Duramed Research, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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