Hot FlashesPhase 4NCT00195520
Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
A Phase 4 study testing Totelle® in people with Hot Flashes and Sleep Disorders, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in Brazil.
Trial summary
To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Hot Flashes, Sleep Disorders
- What is being tested?
- Totelle®
- How many people
- 100 participants
- Where
- 2 sitesBrazil
- Study dates
- Dec 2004to Dec 2006
- Phase
- Phase 4
- 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Intact uterus
- Generally health postmenopausal women 45 to 60 years of age, inclusive
- Sexually active
- No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.
Who cannot join
- Known or suspect estrogen-dependent neoplasia
- Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
- Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Study site
Jundiaí, São Paulo, 13209-000
Study site
São Paulo, São Paulo, 04062-003
About this study
Official title: An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
- Conditions
- Hot Flashes, Sleep Disorders
- Being tested
- Totelle®
- Keywords
- Menopause, Sleep Disorder, Hot Flashes
- Medical subject headings
- Hot Flashes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totelle®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
Secondary outcomes (1)
To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2004
- Study completionDec 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195520
- Sponsor's protocol ID
- 0753T-101537
- Status last verified
- Aug 2008
- First submitted
- 12 Sep 2005
- Last updated
- 5 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
- ClinicalTrials.gov ID
- NCT00195520
- Acronym / sponsor ID
- 0753T-101537
- Conditions
- Hot Flashes, Sleep Disorders
- Keywords
- Menopause, Sleep Disorder, Hot Flashes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Sep 2005 (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.
To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Intact uterus
- Generally health postmenopausal women 45 to 60 years of age, inclusive
- Sexually active
- No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.
Key exclusion criteria (3 listed)
- Known or suspect estrogen-dependent neoplasia
- Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
- Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.
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 |
|---|---|---|
| Totelle® | Drug | – |
Primary outcome
To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
1 secondary outcome
To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
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 5 Aug 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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Totelle® in people with Hot Flashes and Sleep Disorders, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in Brazil.
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 4 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 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.. 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 5 Aug 2008.