Postmenopausal SymptomsPhase 3NCT00905723
The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
A Phase 3 study testing estradiol and isoflavone in people with Postmenopausal Symptoms, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- estradiol and isoflavone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to May 2010
- 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged 45-65 years old
- presenting climacteric symptoms
- sexual complaints
Who cannot join
- hormonal therapy
- counter indication to hormonal therapy
- uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ambulatório de Ginecologia Endócrina
São Paulo, São Paulo, 04039-060
Maria Cecília Santos, Nurse, 5511-55496174, mc.santos@hotmail.com
Teresa R Embiruçu, M.D
About this study
Official title: Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.
- Conditions
- Postmenopausal Symptoms
- Being tested
- estradiol, isoflavone, Placebo
- Keywords
- climacterium, sexual life, isoflavone, estrogen, McCoy's sexual questionnaire, Kupperman index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiolDrug
1 mg daily for 6 months
isoflavoneDrug
150 mg isoflavone daily for 6 months
PlaceboDrug
sugar pill daily for six months
| Study group | Role | What they receive |
|---|---|---|
| Estrogen | Experimental | Women randomized to this group will receive daily pills containing 1 mg of estradiol Receives: Drug: estradiol |
| Isoflavone | Experimental | Women randomized to this group will receive daily pills of 150 mg isoflavone Receives: Drug: isoflavone |
| Placebo | Placebo comparator | Women randomized to this group will be administered daily placebo pills Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
McCoy's sexual questionnaire
Measured: at recruitment and six months later
Secondary outcomes (1)
Kupperman's index
Measured: at recruitment and six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Mauro A Aidar, M.D., PhD, Study chair, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905723
- Sponsor's protocol ID
- 0759/08
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 20 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women
- ClinicalTrials.gov ID
- NCT00905723
- Acronym / sponsor ID
- 0759/08
- Conditions
- Postmenopausal Symptoms
- Keywords
- climacterium, sexual life, isoflavone, estrogen, McCoy's sexual questionnaire, Kupperman index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2010 (estimated)
- First posted
- 20 May 2009 (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.
Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Estrogen | Experimental | Drug: estradiolWomen randomized to this group will receive daily pills containing 1 mg of estradiol |
| Isoflavone | Experimental | Drug: isoflavoneWomen randomized to this group will receive daily pills of 150 mg isoflavone |
| Placebo | Placebo comparator | Drug: PlaceboWomen randomized to this group will be administered daily placebo pills |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women aged 45-65 years old
- presenting climacteric symptoms
- sexual complaints
Key exclusion criteria (3 listed)
- hormonal therapy
- counter indication to hormonal therapy
- uncontrolled comorbidities
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 |
|---|---|---|
| estradiol1 mg daily for 6 months | Drug | Estrogen |
| isoflavone150 mg isoflavone daily for 6 months | Drug | Isoflavone |
| Placebosugar pill daily for six months | Drug | Placebo |
Primary outcome
McCoy's sexual questionnaire
Time frame: at recruitment and six months later
1 secondary outcome
Kupperman's index
Time frame: at recruitment and six months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
- Universidade Federal de São Paulo's web pageLink provided by the sponsor.
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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.
Mauro A Aidar, M.D., PhD study chair
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing estradiol and isoflavone in people with Postmenopausal Symptoms, run by Federal University of São Paulo at 1 site 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 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: status not confirmed, as of the sponsor's last update on 20 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa R Embiruçu, M.D. (5511-75413521, embirucu2@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McCoy's sexual questionnaire (time frame: at recruitment and six months later). 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 20 May 2009.