Postmenopausal Women With Moderate Vasomotor SymptomsPhase 4TRYSEMNCT01116310
Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause
A Phase 4 study testing Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L) in people with Postmenopausal Women With Moderate Vasomotor Symptoms, run by Laboratorios Casen-Fleet S.L.U. at 20 sites in Spain.
Trial summary
The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Postmenopausal Women With Moderate Vasomotor Symptoms
- What is being tested?
- Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 20 sitesSpain
- Study dates
- Apr 2010to Jul 2012
- 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
- Women between 45 and 60 years of age.
- Women in, the immediate or established postmenopausal phase, defined as women with: a) 12 months or more spontaneous amenorrhea or b) 6 months or more spontaneous amenorrhea with levels of follicular stimulating hormone (FSH) above 40 mIU / ml.
- Women with between 35 and 70 episodes of hot flashes (9 or more hot flashes should be of at least moderate intensity) in the week prior to the pre-inclusion period with placebo
- Women who have given written informed consent.
Who cannot join
- Women with surgical menopause.
- Treatment with HRT within 6 months of the screening visit.
- Patients who needs oncological or immunosuppressive treatment during the expected follow-up period.
- Patient with difficult follow-up or with psycho-neurological problems that hinder proper assessment (alcoholism, depression not caused by menopause, etc.)
- Patients who, at the discretion of the investigator, can not be evaluated according to criteria established in this protocol
- Patients following a vegetarian diet
Show all 21Show fewer
- Patients with any relevant gastrointestinal disease
- Patients with a prior diagnosis of hypothyroidism or other clinically relevant thyroid disorder.
- Patients treated and / or diagnosed or with suspicion of cancer.
- Patients with diabetes mellitus who require insulin therapy.
- Patients with current diagnosis of an affective disorder (e.g. depression), anxiety disorder, or psychotic disorder.
- Patients with an organic mental disorder
- Patients with neuropathic pain or any other form of pain that receive or need treatment with antidepressives or anticonvulsivants.
- Patients receiving or requiring treatment with antidepressives or anticonvulsivants for other motives (for example, prevention of the migraine).
- Patients consuming more than 2 alcoholic drinks (16-20 gr.) per day
- Patients who have been treated with antibiotics within 3 months of the screening visit.
- Patients receiving or requiring treatment with clonidine or vitamin E.
- Patients who are treated with NSAIDs
- Patients allergic to any of the components of FITOGYN
- Patients who took less than 80% of the capsules in the pre-inclusion period with placebo.
- Patients whose weekly number of hot flushes is reduced by 25% or more during the pre-inclusion period as compared to the week prior to the initiation of that period.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites, 13 recruiting
- Withdrawn
Hospital Central de Asturias
Asturias, H. Central de Asturias
- Recruiting
Hospital del Cruces
Barakaldo, 48903
José L. Neyro, Dr.
- Withdrawn
Assir CAP Sant Martí
Barcelona, 08020
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Misericordia Guinot, Dr.
- Active, not recruiting
USP Instituto Universitario Dexeus
Barcelona, 08028
- Active, not recruiting
ASSIR CAP San Andreu
Barcelona, 08030
- Recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Francesc Baró, Dr.
- Recruiting
Hospital Monteprincipe
Boadilla Del Monte, Madrid, 28660
Manuel Marcos, Dr.
- Active, not recruiting
Hospital General de Ciudad Real
Ciudad Real, 13005
- Recruiting
Centro Diatros
Gavá (Barcelona), 08850
Rafael Sánchez Borrego, Dr.
- Recruiting
Hospital Universitario de Guadalajara
Guadalajara, 19002
María J. Cancelo, Dr.
- Recruiting
Consorci Sanitari d l´Anoia-H. de Igualada
Igualada, Barcelona, 08700
Ana R Pérez Aguado, Dr.
- Recruiting
Centro de Estudios de Obstetricia y Ginecología Asociado Lugo
Lugo, 27002
Francisco Vázquez, Dr.
- Recruiting
Gabinete Médico Velázquez
Madrid, 28001
Silvia González, Dr.
- Recruiting
Instituto Palacios
Madrid, 28009
Santiago Palacios, Dr.
- Withdrawn
Hospital Mateu Orfila
Maó, 07701
- Recruiting
H. San Joan d'Alacant
San Juan, Alicante, 03550
Francisco Quereda, Dr.
- Recruiting
Hospital Universitario La Fe
Valencia, 46009
Dolores Juliá, Dr.
- Recruiting
Hospital Doctor Pesset
Valencia, 46017
Antonio Cano, Dr.
- Withdrawn
Hospital Miguel Servet
Zaragoza, 50009
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Tolerability of the Combination of Soy Isoflavones and Red Clover Extract (FITOGYN) in the Treatment of the Hot Flushes in Menopausal Women.
The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause.
Read the detailed description
One of the most significant problems for assessing treatment of hot flushes is the placebo effect. A Phase IV study with an innovative design, intended to additionally assess such effect, is reported. The efficacy of Fitogyn for the treatment of hot flushes in menopausal women with moderate symptoms will be assessed. Secondary objectives will include evaluation of the impact of Fitogyn as compared to placebo on overall menopause symptoms (fatigue, joint pain, vaginal dryness, and sleep disturbances), anxiety, quality of life, and cardiovascular parameters. Equol levels in blood will also be measured to study its potential impact on the outcome of treatment with these isoflavones.
The duration of the study participants will be 22 weeks. 7 visits are planned during the study:
After the screening visit (visit 1), women selected will report on the daily occurrence of hot flushes for 2 weeks without treatment. If they experience the required number of hot flushes (35-70 hot flushes in the prior week and 9 or more of them with at least moderate intensity), a 4-week placebo run-in period will start (visit 2). After this time (Visit 3), women with a decrease lower than 25% in the number of hot flushes and a treatment adherence of at least 80% will be randomised to receive treatment (Fitogyn vs placebo) for 16 weeks.
During visit 3, baseline assessments of primary and secondary variables will be carried out. Additionally, blood and urine samples will be obtained to conduct hematological and biochemical tests, and assess thyroid function and lipid profile. In addition, patients will complete the following scales: "Menopausal Rating Scale (MRS)", the scales of anxiety (HADS) and quality of life (Scale of Cervantes).
Visits 4, 5 and 6: To assess every 4 weeks the treatment adherence, to do a safety evaluation and daily collection of hot flashes.
Visit 7: End of study (week 22 of study). During this visit the same activities described for visit 3 will be performed.
SUBSTUDY:
TITLE: "Evaluating the impact of the combination of soy isoflavones and red clover extract (FITOGYN) compared to placebo on some markers of atherogenesis"
The substudy will be conducted in a subsample of approximately 90 patients and will involve those Investigational Sites willing to conduct the substudy, given that they have the means for the proper and correct handling of samples. This study has an exploratory purpose, and will provide useful insight into the specific mechanisms of action of phytoestrogens as well as generate new hypotheses that can guide future research on this product. Additionally, blood equol levels will be measured to study their potential effect on treatment outcome with these isoflavones.
A number of biological parameters have been identified that are clearly related to the process of atherogenesis. This measurement would be from blood collections performed at baseline and the end of the trial, so that new blood collections will not be necessary beyond those already planned.
The selected parameters are:
- Level of insulin resistance from HOMA.
- Low density lipoprotein (LDL), oxidized (ox LDL) concentration.
- Asymmetric dimethyl arginine concentration in endothelial cell culture
- Measure the ratio of prostacyclin / thromboxane in urine.
- Genesis of tissue factor in the endothelium.
- Measurement of blood levels of equol.
- Being tested
- Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L), Placebo
- Keywords
- Hot flushes, Hot flashes, menopause, postmenopause, Soy isoflavones, Red clover, Equol
- 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 isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)Drug
Also called Fitogyn
Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones
PlaceboDrug
Bottles containing 60 capsules.
| Study group | Role | What they receive |
|---|---|---|
| Fitogyn | Experimental | 4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast. Receives: Drug: Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L); Drug: Placebo |
| Placebo | Placebo comparator | 20 weeks with placebo, taking two capsules per day during the breakfast. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the number of symptoms of hot flashes (including night sweats) at the end of the study (week 22) with respect to baseline (week 6).
This change will be expressed in absolute value and proportion of reduction with regard to the number basal of symptoms reported in the last week of the period of pre inclusion. The average or average of the reduction of hot flushes in every week of treatment and at the end of the treatment will be compared. This information will be obtained for every group and recorded by the women using a "hot flushes diary".
Additionally, the average change will be evaluated using the hot flash score (frequency combined with intensity) following the same methodology.
Measured: 16 weeks
Secondary outcomes (6)
Intensity of Hot Flashes
Intensity of the hot flushes that the participants communicate in the "hot flushes diary". The variable "intensity" of symptoms will be gathered in the categories of "mild", "moderate", "intense" and "very intense ", according to Sloan et al. J clin Oncol. 2001 dec 1;19 (23):4280-90 definitions.
Measured: 16 weeks
Impact of the treatment with FITOGYN on the overall symptoms of menopause: fatigue, joint pain, vaginal dryness and sleep disturbances among others.
The information about symptoms of the menopause will be gathered across Heinemann's Menopause Rating Scale (Self-administered instrument that evaluates 11 symptoms of menopause on a 5-point scale from 0, no symptom, to 4, extremely severe symptom. The total score includes 3 dimensions or factors: psychological, somato-vegetative, and urogenital. The overall score will be obtained for each domain and assessed at baseline and after 16 weeks of treatment.)
Measured: 16 weeks
Effect of the treatment with FITOGYN in the level of anxiety of postmenopausal women.
The anxiety subscale of the Hospital Anxiety-Depression Scale (HADS) will be used. HADS is a self-administered instrument comprised of 14 items (7 explore symptoms of depression and 7 others explore symptoms of anxiety). Each item is scored from 0 to 3 where 0 represents no symptom and 3 the most severe or frequent symptoms. Two scores are obtained by summing the 7 items of each sub-scale, depression and anxiety (HADS-D and HADS-A), with a score range for each from 0 to 21. The overall score will be obtained and for the anxiety domain assessed at baseline and after 16 weeks of treatment.
Measured: 16 weeks
Effect of the treatment with FITOGYN in the quality of life of postmenopausal women.
The Scale of Cervantes will be used to evaluate quality of life. It consists of 31 items that are distributed in the following dimensions:
- Menopause and health (15 items assessing vasomotor symptoms, health and aging)
- Sexuality (4 items)
- Relationships (3 items)
- Psychic domain (9 items) The overall score will be obtained and assessed for each domain at baseline and after 16 weeks of treatment.
Measured: 16 weeks
Evaluate the change in the subject's lipidic profile.
The average difference in mm/dL between baseline and after 16 weeks of treatment will be determined.
Measured: 16 weeks
Evaluation of the safety and tolerability.
The average difference between baseline and after 16 weeks of treatment in some haematological (Haemoglobin, WBC Differential Count and platelets), biochemistry (standard biochemistry witch include at least Lactate dehydrogenase, cholesterol, triglycerides and thyroid function) and urinalysis parameters will be determined.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women With Moderate Vasomotor 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Casen-Fleet S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L., Asociacion Colaboracion Cochrane Iberoamericana
- Responsible party
- Sponsor
- Investigators
- Joaquím Calaf, Dr., Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauCano Antonio, Dr., Study chair, Hospital Doctor Pesset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116310
- Sponsor's protocol ID
- LCF-GIN-2008-EC02
- Acronym
- TRYSEM
- Status last verified
- Sep 2011
- First submitted
- 3 May 2010
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate the Efficacy and Tolerability of the Combination of Soy Isoflavones and Red Clover Extract (FITOGYN) in the Treatment of the Hot Flushes in Menopausal Women.
- ClinicalTrials.gov ID
- NCT01116310
- Acronym / sponsor ID
- TRYSEM / LCF-GIN-2008-EC02
- Keywords
- Hot flushes, Hot flashes, menopause, postmenopause, Soy isoflavones, Red clover, Equol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Laboratorios Casen-Fleet S.L.U.Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L., Asociacion Colaboracion Cochrane Iberoamericana
- Study start
- Apr 2010
- Primary completion
- May 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 4 May 2010 (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 evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause.
Detailed description
One of the most significant problems for assessing treatment of hot flushes is the placebo effect. A Phase IV study with an innovative design, intended to additionally assess such effect, is reported. The efficacy of Fitogyn for the treatment of hot flushes in menopausal women with moderate symptoms will be assessed. Secondary objectives will include evaluation of the impact of Fitogyn as compared to placebo on overall menopause symptoms (fatigue, joint pain, vaginal dryness, and sleep disturbances), anxiety, quality of life, and cardiovascular parameters. Equol levels in blood will also be measured to study its potential impact on the outcome of treatment with these isoflavones.
The duration of the study participants will be 22 weeks. 7 visits are planned during the study:
After the screening visit (visit 1), women selected will report on the daily occurrence of hot flushes for 2 weeks without treatment. If they experience the required number of hot flushes (35-70 hot flushes in the prior week and 9 or more of them with at least moderate intensity), a 4-week placebo run-in period will start (visit 2). After this time (Visit 3), women with a decrease lower than 25% in the number of hot flushes and a treatment adherence of at least 80% will be randomised to receive treatment (Fitogyn vs placebo) for 16 weeks.
During visit 3, baseline assessments of primary and secondary variables will be carried out. Additionally, blood and urine samples will be obtained to conduct hematological and biochemical tests, and assess thyroid function and lipid profile. In addition, patients will complete the following scales: "Menopausal Rating Scale (MRS)", the scales of anxiety (HADS) and quality of life (Scale of Cervantes).
Visits 4, 5 and 6: To assess every 4 weeks the treatment adherence, to do a safety evaluation and daily collection of hot flashes.
Visit 7: End of study (week 22 of study). During this visit the same activities described for visit 3 will be performed.
SUBSTUDY:
TITLE: "Evaluating the impact of the combination of soy isoflavones and red clover extract (FITOGYN) compared to placebo on some markers of atherogenesis"
The substudy will be conducted in a subsample of approximately 90 patients and will involve those Investigational Sites willing to conduct the substudy, given that they have the means for the proper and correct handling of samples. This study has an exploratory purpose, and will provide useful insight into the specific mechanisms of action of phytoestrogens as well as generate new hypotheses that can guide future research on this product. Additionally, blood equol levels will be measured to study their potential effect on treatment outcome with these isoflavones.
A number of biological parameters have been identified that are clearly related to the process of atherogenesis. This measurement would be from blood collections performed at baseline and the end of the trial, so that new blood collections will not be necessary beyond those already planned.
The selected parameters are:
- Level of insulin resistance from HOMA.
- Low density lipoprotein (LDL), oxidized (ox LDL) concentration.
- Asymmetric dimethyl arginine concentration in endothelial cell culture
- Measure the ratio of prostacyclin / thromboxane in urine.
- Genesis of tissue factor in the endothelium.
- Measurement of blood levels of equol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitogyn | Experimental | Drug: Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L), Drug: Placebo4 weeks with placebo followed by 16 weeks with Fitogyn, both taking two capsules per day during the breakfast. |
| Placebo | Placebo comparator | Drug: Placebo20 weeks with placebo, taking two capsules per day during the breakfast. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 45 and 60 years of age.
- Women in, the immediate or established postmenopausal phase, defined as women with: a) 12 months or more spontaneous amenorrhea or b) 6 months or more spontaneous amenorrhea with levels of follicular stimulating hormone (FSH) above 40 mIU / ml.
- Women with between 35 and 70 episodes of hot flashes (9 or more hot flashes should be of at least moderate intensity) in the week prior to the pre-inclusion period with placebo
- Women who have given written informed consent.
Key exclusion criteria (21 listed)
- Women with surgical menopause.
- Treatment with HRT within 6 months of the screening visit.
- Patients who needs oncological or immunosuppressive treatment during the expected follow-up period.
- Patient with difficult follow-up or with psycho-neurological problems that hinder proper assessment (alcoholism, depression not caused by menopause, etc.)
- Patients who, at the discretion of the investigator, can not be evaluated according to criteria established in this protocol
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 isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)Also: FitogynBottles containing 60 capsules, 53.5 mg/capsule of isoflavones | Drug | Fitogyn |
| PlaceboBottles containing 60 capsules. | Drug | Fitogyn, Placebo |
Primary outcome
Mean Change in the number of symptoms of hot flashes (including night sweats) at the end of the study (week 22) with respect to baseline (week 6).
Time frame: 16 weeks
This change will be expressed in absolute value and proportion of reduction with regard to the number basal of symptoms reported in the last week of the period of pre inclusion. The average or average of the reduction of hot flushes in every week of treatment and at the end of the treatment will be compared. This information will be obtained for every group and recorded by the women using a "hot flushes diary". Additionally, the average change will be evaluated using the hot flash score (frequency combined with intensity) following the same methodology.
6 secondary outcomes
Intensity of Hot Flashes
Time frame: 16 weeks
Impact of the treatment with FITOGYN on the overall symptoms of menopause: fatigue, joint pain, vaginal dryness and sleep disturbances among others.
Time frame: 16 weeks
Effect of the treatment with FITOGYN in the level of anxiety of postmenopausal women.
Time frame: 16 weeks
Effect of the treatment with FITOGYN in the quality of life of postmenopausal women.
Time frame: 16 weeks
Evaluate the change in the subject's lipidic profile.
Time frame: 16 weeks
Evaluation of the safety and tolerability.
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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Vasomotor Symptoms
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.
Joaquím Calaf, Dr. study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Cano Antonio, Dr. study chair
Hospital Doctor Pesset
20 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 Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L) in people with Postmenopausal Women With Moderate Vasomotor Symptoms, run by Laboratorios Casen-Fleet S.L.U. at 20 sites in Spain.
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 21 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 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos J. Badiola, M.D. (+34 91 352 83 70, cjbadiola@casenfleet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in the number of symptoms of hot flashes (including night sweats) at the end of the study (week 22) with respect to baseline (week 6). (time frame: 16 weeks). 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 28 Sep 2011.