Hot FlashesPhase 3NCT00272935
A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes
A Phase 3 study testing Cenestin 0.3 mg Tablets in people with Hot Flashes, run by Duramed Research at 49 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Cenestin 0.3 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 49 sitesUnited States
- Study dates
- Dec 2005to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any contraindication to natural or synthetic estrogens
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Duramed Investigational Site
Albuquerque, New Mexico, 87102
Duramed Investigational Site
Alpharetta, Georgia, 30005
Duramed Investigational Site
Baltimore, Maryland, 21224
Duramed Investigational Site
Boise, Idaho, 83712
Duramed Investigational Site
Bristol, Tennessee, 37620
Duramed Investigational Site
Brooksville, Florida, 34613
Duramed Investigational Site
Carmichael, California, 95608
Duramed Investigational Site
Charleston, South Carolina, 29401
Duramed Investigational Site
Clarksville, Tennessee, 37043
Duramed Investigational Site
Cleveland, Ohio, 44122
Duramed Investigational Site
Columbus, Ohio, 43213
Duramed Investigational Site
Coral Gables, Florida, 33134
Duramed Investigational Site
Dallas, Texas, 75390
Duramed Investigational Site
Douglasville, Georgia, 30134
Duramed Investigational Site
Evansville, Indiana, 47714
Duramed Investigational Site
Fort Worth, Texas, 76104
Duramed Investigational Site
Gainesville, Florida, 32607
Duramed Investigational Site
Houston, Texas, 77015
Duramed Investigational Site
Houston, Texas, 77030
Duramed Investigational Site
Houston, Texas, 77074
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Irvine, California, 92618
Duramed Investigational Site
King of Prussia, Pennsylvania, 19406
Duramed Investigational Site
Las Vegas, Nevada, 89146
Duramed Investigational Site
Leesburg, Florida, 34748
Duramed Investigational Site
Lexington, Kentucky, 40509
Duramed Investigational Site
Lincoln, Nebraska, 68510
Duramed Investigational Site
Mayfield Heights, Ohio, 44124
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Miami, Florida, 33143
Duramed Investigational Site
Montgomery, Alabama, 36116
Duramed Investigational Site
Nashville, Tennessee, 37203
Duramed Investigational Site
Norfolk, Virginia, 23507
Duramed Investigational Site
North Wales, Pennsylvania, 19454
Duramed Investigational Site
Palm Springs, Florida, 33461
Duramed Investigational Site
Philadelphia, Pennsylvania, 19107
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Phoenix, Arizona, 85013
Duramed Investigational Site
Phoenix, Arizona, 85032
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 72108
Duramed Investigational Site
San Diego, California, 92103
Duramed Investigational Site
San Diego, California, 92123
Duramed Investigational Site
San Ramon, California, 94583
Duramed Investigational Site
Spokane, Washington, 92207
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tucson, Arizona, 85712
Duramed Investigational Site
Venice, Florida, 34285
About this 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
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
- Conditions
- Hot Flashes
- Being tested
- Cenestin 0.3 mg Tablets, Placebo
- Keywords
- menopause, vasomotor symptoms
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenestin 0.3 mg TabletsDrug
Also called Synthetic conjugated estrogens, A
1 tablet daily
PlaceboOther
Also called Placebo tablets
1 tablet daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Cenestin 0.3 mg Tablets |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in average frequency of moderate to severe hot flashes
Measured: Baseline to Day 28 and to Day 84
Mean change in severity of moderate to severe hot flashes
Measured: Baseline to Day 28 and to Day 84
Secondary outcomes (1)
Safety and tolerability of Cenestin 0.3mg
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duramed Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Duramed Research Protocol Chair, Study chair, Duramed Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272935
- Sponsor's protocol ID
- BR-CEN-301
- Status last verified
- Jul 2009
- First submitted
- 4 Jan 2006
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00272935
- Acronym / sponsor ID
- BR-CEN-301
- Conditions
- Hot Flashes
- Keywords
- menopause, vasomotor symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Duramed ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cenestin 0.3 mg Tablets |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any contraindication to natural or synthetic estrogens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cenestin 0.3 mg TabletsAlso: Synthetic conjugated estrogens, A1 tablet daily | Drug | 1 |
| PlaceboAlso: Placebo tablets1 tablet daily | Other | 2 |
Primary outcome
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
1 secondary outcome
Safety and tolerability of Cenestin 0.3mg
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
Related trials for Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duramed Research Protocol Chair study chair
Duramed Research, Inc
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cenestin 0.3 mg Tablets in people with Hot Flashes, run by Duramed Research at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in average frequency of moderate to severe hot flashes (time frame: Baseline to Day 28 and to Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.