PostmenopausePhase 3NCT00235924
Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women
A Phase 3 study testing soy isoflavone in people with Postmenopause, run by Laboratoires Arkopharma.
Trial summary
The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopause
- What is being tested?
- soy isoflavone
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to not given
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Not hysterectomised women
- Post menopausal (at least 2 years)
- FSH superior to 30 UI/l and oestradiol inferior to 35 ng/ml
- Presenting with hot flushes (but not incapacitating) or climacteric symptoms
Who cannot join
- History of endometrial hyperplasia
- Known hormono-dependent malignant tumours
- BMI superior to 30 Kg/m2
- Uncontrolled arterial hypertension
- Known renal or liver insufficiency
- Recent or evolutive thromboembolic disease
Show all 11Show fewer
- Unexplained bleeding, endometrial polyps, submucous myomas, active endometriosis, ovarian cyst superior to 30 mm
- Local hormonal treatment, raloxifene,tibolone within the 3 months before V1 and during the study
- HRT and DHEA within the 3 months before V2 and during the study
- isoflavones within the 2 months before V2 and during the study
- clonidine, beta-alanine, veralipride within 1 month before V1 and during the study.
About this study
Official title: Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.
The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.
Read the detailed description
This is an international multicentre open study, assessing the innocuity on breast and endometrium of a 70 mg daily dose of isoflavones standardized extract (Phytosoya).
This study follows the European guidelines :one-year treatment duration, biopsy and mammography performed at the beginning and at the end of the trial, recruitment of enough subjects in order to have 300 patients with an evaluable biopsy after one year of treatment.
After 3 weeks of screening phase, the patients will be taken Phytosoya during 52 weeks. At the end of the first year of treatment, an endometrial biopsy, an endovaginal ultrasonography, a mammography, breast ultrasounds, a clinical examination and a biological assessment will be performed.
In addition, it will be proposed to patients to continue treatment during 2 additional years. At the end of the third year,the same examinations will be performed.
- Conditions
- Postmenopause
- Being tested
- soy isoflavone
- Keywords
- menopause, isoflavone, endometrial safety, breast innocuity assessment, hot flushes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy isoflavoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Endometrial innocuity (endometrial biopsy result)
Secondary outcomes (4)
- Mammary innocuity (mammography results)
- climacteric symptoms
-Lipid profile
-gynaecological and general safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Laboratoires Arkopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pierre MARES, Professor, Study chair, Hospital of Caremeau, Nîmes, FRANCESantiago PALACIOS, Professor, Principal investigator, Instituto Palacios, Madrid, SPAINBruno PORNEL, Doctor, Principal investigator, Brussels Menopause Center, Bruxelles, BELGIUMJohn EDEN, Professor, Principal investigator, Sydney Menopause Center, Sydney, AUSTRALIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235924
- Sponsor's protocol ID
- PHY04GE01
- Status last verified
- Oct 2005
- First submitted
- 7 Oct 2005
- Last updated
- 8 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing the Effects on Endometrium and Breast of a Standardized Isoflavone Extract(Phytosoya) in Post Menopausal Women.
- ClinicalTrials.gov ID
- NCT00235924
- Acronym / sponsor ID
- PHY04GE01
- Conditions
- Postmenopause
- Keywords
- menopause, isoflavone, endometrial safety, breast innocuity assessment, hot flushes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Laboratoires ArkopharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- First posted
- 12 Oct 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.
The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.
Detailed description
This is an international multicentre open study, assessing the innocuity on breast and endometrium of a 70 mg daily dose of isoflavones standardized extract (Phytosoya).
This study follows the European guidelines :one-year treatment duration, biopsy and mammography performed at the beginning and at the end of the trial, recruitment of enough subjects in order to have 300 patients with an evaluable biopsy after one year of treatment.
After 3 weeks of screening phase, the patients will be taken Phytosoya during 52 weeks. At the end of the first year of treatment, an endometrial biopsy, an endovaginal ultrasonography, a mammography, breast ultrasounds, a clinical examination and a biological assessment will be performed.
In addition, it will be proposed to patients to continue treatment during 2 additional years. At the end of the third year,the same examinations will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Not hysterectomised women
- Post menopausal (at least 2 years)
- FSH superior to 30 UI/l and oestradiol inferior to 35 ng/ml
- Presenting with hot flushes (but not incapacitating) or climacteric symptoms
Key exclusion criteria (11 listed)
- History of endometrial hyperplasia
- Known hormono-dependent malignant tumours
- BMI superior to 30 Kg/m2
- Uncontrolled arterial hypertension
- Known renal or liver insufficiency
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 |
|---|---|---|
| soy isoflavone | Drug | – |
Primary outcome
- Endometrial innocuity (endometrial biopsy result)
4 secondary outcomes
- Mammary innocuity (mammography results)
- climacteric symptoms
-Lipid profile
-gynaecological and general safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2005.
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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.
Pierre MARES, Professor study chair
Hospital of Caremeau, Nîmes, FRANCE
Santiago PALACIOS, Professor principal investigator
Instituto Palacios, Madrid, SPAIN
Bruno PORNEL, Doctor principal investigator
Brussels Menopause Center, Bruxelles, BELGIUM
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing soy isoflavone in people with Postmenopause, run by Laboratoires Arkopharma.
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 11 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 8 Dec 2005. 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?
Results are not available in the source record.
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?
- Endometrial innocuity (endometrial biopsy result). 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 8 Dec 2005.