Postmenopausal SymptomsPhase 3NCT00727129
Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms
A Phase 3 study testing Divigel in people with Postmenopausal Symptoms, run by Upsher-Smith Laboratories.
Trial summary
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Divigel
- How many people
- 495 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Aug 2005
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Have moderate to severe hot flashes
- Normal Pap Smear
Who cannot join
- Abnormal mammogram
- Abnormal clinical breast exam
- BMI >35
About this study
Official title: Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
- Conditions
- Postmenopausal Symptoms
- Being tested
- Divigel
- Keywords
- vasomotor symptoms, estrogen, estradiol, hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivigelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily frequency and severity of moderate to severe vasomotor symptoms
Secondary outcomes (1)
vulvar and vaginal atrophy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJul 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SymptomsStudies 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
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upsher-Smith Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727129
- Sponsor's protocol ID
- P04-001
- Status last verified
- Sep 2008
- First submitted
- 29 Jul 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
Publications
Hedrick RE. Low-dose estradiol gel 0.1% for the treatment of vasomotor symptoms associated with menopause. Expert Review of Obstetrics & Gynecology, 3(2): Pages 155-162, Mar 2008.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients
- ClinicalTrials.gov ID
- NCT00727129
- Acronym / sponsor ID
- P04-001
- Conditions
- Postmenopausal Symptoms
- Keywords
- vasomotor symptoms, estrogen, estradiol, hot flashes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Upsher-Smith LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 1 Aug 2008 (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.
The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women
- Have moderate to severe hot flashes
- Normal Pap Smear
Key exclusion criteria (3 listed)
- Abnormal mammogram
- Abnormal clinical breast exam
- BMI >35
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 |
|---|---|---|
| Divigel | Drug | – |
Primary outcome
Daily frequency and severity of moderate to severe vasomotor symptoms
1 secondary outcome
vulvar and vaginal atrophy
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 26 Sep 2008.
- Results publicationHedrick RE. Low-dose estradiol gel 0.1% for the treatment of vasomotor symptoms associated with menopause. Expert Review of Obstetrics & Gynecology, 3(2): Pages 155-162, Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divigel in people with Postmenopausal Symptoms, run by Upsher-Smith Laboratories.
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 3 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 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Daily frequency and severity of moderate to severe vasomotor symptoms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00727129, which also lists 1 linked publication.
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 26 Sep 2008.