Sexual Dysfunctions, PsychologicalNCT00134316
Cervical or Endometrial Cancer and Sexual Health Study
A study testing psychoeducational intervention in people with Sexual Dysfunctions, Psychological, run by University of British Columbia at 1 site in Canada.
Trial summary
Aim #1. To investigate the efficacy of the psychoeducational intervention (PED) on sexual arousal. H1: Compared to a control group and to baseline, PED will result in significant improvement in: self-reported subjective sexual arousal; self-reported genital sensitivity; psychophysiological sexual arousal. Aim #2. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunctions, Psychological
- What is being tested?
- psychoeducational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Jun 2010
- Phase
- Interventional
- 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 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of cervical or endometrial cancer, in remission for at least 1 year
- Treatment by hysterectomy at least one year earlier
- Diagnosis of female sexual arousal disorder (FSAD) according to DSM-IV-TR criteria with new onset after the hysterectomy
- Currently involved in a relationship
Who cannot join
- Treatment by either radiation or chemotherapy alone
- Current diagnosis of primary hypoactive sexual desire disorder - or in other words, if complaints of sexual desire are present, they must be less distressing than the sexual arousal complaints.
- Unstable psychopathology and Beck Depression Inventory scores greater than 19
- Lack of sexual experience
- Current use of antidepressants or other medication with known sexual side effects
- Those with a physical condition that would impede participation in the psychophysiological assessment
Trial locations and contacts
1 site in 1 country.
About this study
Aim #1. To investigate the efficacy of the psychoeducational intervention (PED) on sexual arousal.
H1: Compared to a control group and to baseline, PED will result in significant improvement in:
Read more
- self-reported subjective sexual arousal;
- self-reported genital sensitivity;
- psychophysiological sexual arousal.
Aim #2. To investigate the efficacy of the PED on self-reported orgasm, sexual desire, distress, and relationship satisfaction.
H2: Compared to a control group and to baseline, PED will result in significant improvement in self-reported orgasmic experience, sexual desire, sexual distress, and relationship satisfaction.
Aim #3. To investigate the efficacy of the PED on depressive symptoms and quality of life.
H3: Compared to a control group and to baseline, PED will result in significant improvement in self-reported depressive symptoms and quality of life.
Read the detailed description
Whereas relatively more research and therapy options exist for physical treatments of sexual dysfunction in women with a history of cervical cancer (e.g. hormone replacement, surgery; Denton \& Maher, 2003), there is some evidence that psychological interventions have positive effects on sexuality. For example, a brief psychoeducational program for women with early-stage cervical cancer resulted in significant improvements in the frequency of coital activity (Capone et al., 1980), and enhanced compliance with sexual rehabilitation, reduced fear about intercourse and improved sexual knowledge compared to a control condition (Robinson et al., 1999). Unfortunately, neither study targeted nor assessed sexual arousal or genital sensations - symptoms documented to be most problematic and distressing in this group of women. There is also evidence that providing a venue for women to receive education and discuss sexual concerns following cervical cancer is therapeutic as it might encourage women to be more aware of their sexual rehabilitation and capacity for change, thus evoking a more active coping style (Leenhouts et al., 2002). Taken together, these studies suggest that psychoeducational interventions are feasible and significantly improve general domains of sexual function, such as sexual frequency and knowledge, in cervical cancer survivors.
Although directly targeting psychological constructs such as thoughts, affect, and behaviour, psychological treatments can also evoke physiological change. In cervical cancer-related sexual dysfunction where the psychological and physical contributors of impairment are difficult to tease apart, a psychoeducational intervention that addresses both etiological domains is essential. We have recently developed a 3-session psychoeducational intervention designed to address both the physical and psychological consequences of cervical cancer on sexual arousal. The sexual arousal concerns reported by this group of women fit the criteria for Female Sexual Arousal Disorder (FSAD), defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revised (DSM-IV-TR) as "persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement" where "the disturbance causes marked distress or interpersonal difficulty" (American Psychiatric Association, 2000). A proportion of these women also experience new onset difficulties becoming subjectively sexually aroused, likely as a direct result of the genital arousal difficulties, but also due to the impact of cancer and hysterectomy on psychological function. Despite the wide prevalence of such subjective arousal concerns, this is not a diagnostic category in the DSM-IV-TR. However, the International Consultation on Sexual Dysfunctions, in collaboration with the World Health Organization, has suggested that "Subjective Sexual Arousal Disorder" be recognized as a valid concern (Basson et al., 2003). Evidence-based treatments for FSAD related to genital or subjective arousal difficulties do not exist, and persisting distress due to untreated sexual dysfunction can compromise mental and physical health. The contents of our psychoeducational intervention were based on:
- empirically supported techniques in other areas of female sexual dysfunction (e.g., sensate focus, challenging of maladaptive cognitions and sexual myths);
- discussions with gynecological oncologists at the University of Washington who are usually the first-line recipients of such sexual complaints; and
- pilot interviews conducted with 18 cervical and endometrial cancer survivors to date.
The intervention focuses primarily on sexual arousal, both genital and subjective, and secondarily on the interaction between cervical cancer and hysterectomy with relationship satisfaction, body image, and beliefs about health.
- Conditions
- Sexual Dysfunctions, Psychological
- Being tested
- psychoeducational intervention
- Keywords
- sexual dysfunction
- Medical subject headings
- Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducational interventionBehavioural
three 75 minute long individual psychoeducational sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
Upon completion of data analysis, establishment of the efficacy of a psychoeducational intervention (PED) in a sample of cervical or endometrial cancer survivors with sexual arousal disorder will be determined.
Measured: upon completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionNov 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunctions, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Rosemary Basson, FCRP (UK), Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134316
- Sponsor's protocol ID
- UBC-SH-CECSH.P1&2-20R91396
- Other IDs
- CIHR-PG#20R91396
- Status last verified
- Feb 2011
- First submitted
- 22 Aug 2005
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Butler L, Banfield V, Sveinson T, Allen K. Conceptualizing sexual health in cancer care. West J Nurs Res. 1998 Dec;20(6):683-99; discussion 700-5. doi: 10.1177/019394599802000603.
PubMed 9842287Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical and simple hysterectomy: a quantitative study of nerve types in the uterine supporting ligaments. J Soc Gynecol Investig. 2002 Jan-Feb;9(1):47-56. doi: 10.1016/s1071-5576(01)00145-9.
PubMed 11839509Grumann M, Robertson R, Hacker NF, Sommer G. Sexual functioning in patients following radical hysterectomy for stage IB cancer of the cervix. Int J Gynecol Cancer. 2001 Sep-Oct;11(5):372-80. doi: 10.1046/j.1525-1438.2001.01051.x.
PubMed 11737468Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology. 2003 Apr-May;12(3):267-79. doi: 10.1002/pon.639.
PubMed 12673810Kylstra WA, Leenhouts GH, Everaerd W, Panneman MJ, Hahn DE, Weijmar Schultz WC, Van De Wiel HB, Heintz AP. Sexual outcomes following treatment for early stage gynecological cancer: a prospective multicenter study. Int J Gynecol Cancer. 1999 Sep;9(5):387-395. doi: 10.1046/j.1525-1438.1999.99052.x.
PubMed 11240799Robinson JW, Faris PD, Scott CB. Psychoeducational group increases vaginal dilation for younger women and reduces sexual fears for women of all ages with gynecological carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):497-506. doi: 10.1016/s0360-3016(99)00048-6.
PubMed 10348277Wenzel LB, Donnelly JP, Fowler JM, Habbal R, Taylor TH, Aziz N, Cella D. Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study. Psychooncology. 2002 Mar-Apr;11(2):142-53. doi: 10.1002/pon.567.
PubMed 11921330Andersen BL, Woods XA, Copeland LJ. Sexual self-schema and sexual morbidity among gynecologic cancer survivors. J Consult Clin Psychol. 1997 Apr;65(2):221-9. doi: 10.1037//0022-006x.65.2.221.
PubMed 9086685Anderson BJ, Wolf FM. Chronic physical illness and sexual behavior: psychological issues. J Consult Clin Psychol. 1986 Apr;54(2):168-75. doi: 10.1037//0022-006x.54.2.168. No abstract available.
PubMed 3700803Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000 Aug 15;89(4):834-41. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-7.
PubMed 10951347Capone MA, Good RS, Westie KS, Jacobson AF. Psychosocial rehabilitation of gynecologic oncology patients. Arch Phys Med Rehabil. 1980 Mar;61(3):128-32.
PubMed 7369850Leenhouts GH, Kylstra WA, Everaerd W, Hahn DE, Schultz WC, van de Wiel HB, Heintz AP. Sexual outcomes following treatment for early-stage gynecological cancer: a prospective and cross-sectional multi-center study. J Psychosom Obstet Gynaecol. 2002 Jun;23(2):123-32. doi: 10.3109/01674820209042794.
PubMed 12189897Basson R, Brotto LA. Sexual psychophysiology and effects of sildenafil citrate in oestrogenised women with acquired genital arousal disorder and impaired orgasm: a randomised controlled trial. BJOG. 2003 Nov;110(11):1014-24.
PubMed 14592587
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical or Endometrial Cancer and Sexual Health Study
- ClinicalTrials.gov ID
- NCT00134316
- Acronym / sponsor ID
- UBC-SH-CECSH.P1&2-20R91396
- Conditions
- Sexual Dysfunctions, Psychological
- Keywords
- sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Aug 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.
Aim #1. To investigate the efficacy of the psychoeducational intervention (PED) on sexual arousal.
H1: Compared to a control group and to baseline, PED will result in significant improvement in:
- self-reported subjective sexual arousal;
- self-reported genital sensitivity;
- psychophysiological sexual arousal.
Aim #2. To investigate the efficacy of the PED on self-reported orgasm, sexual desire, distress, and relationship satisfaction.
H2: Compared to a control group and to baseline, PED will result in significant improvement in self-reported orgasmic experience, sexual desire, sexual distress, and relationship satisfaction.
Aim #3. To investigate the efficacy of the PED on depressive symptoms and quality of life.
H3: Compared to a control group and to baseline, PED will result in significant improvement in self-reported depressive symptoms and quality of life.
Detailed description
Whereas relatively more research and therapy options exist for physical treatments of sexual dysfunction in women with a history of cervical cancer (e.g. hormone replacement, surgery; Denton \& Maher, 2003), there is some evidence that psychological interventions have positive effects on sexuality. For example, a brief psychoeducational program for women with early-stage cervical cancer resulted in significant improvements in the frequency of coital activity (Capone et al., 1980), and enhanced compliance with sexual rehabilitation, reduced fear about intercourse and improved sexual knowledge compared to a control condition (Robinson et al., 1999). Unfortunately, neither study targeted nor assessed sexual arousal or genital sensations - symptoms documented to be most problematic and distressing in this group of women. There is also evidence that providing a venue for women to receive education and discuss sexual concerns following cervical cancer is therapeutic as it might encourage women to be more aware of their sexual rehabilitation and capacity for change, thus evoking a more active coping style (Leenhouts et al., 2002). Taken together, these studies suggest that psychoeducational interventions are feasible and significantly improve general domains of sexual function, such as sexual frequency and knowledge, in cervical cancer survivors.
Although directly targeting psychological constructs such as thoughts, affect, and behaviour, psychological treatments can also evoke physiological change. In cervical cancer-related sexual dysfunction where the psychological and physical contributors of impairment are difficult to tease apart, a psychoeducational intervention that addresses both etiological domains is essential. We have recently developed a 3-session psychoeducational intervention designed to address both the physical and psychological consequences of cervical cancer on sexual arousal. The sexual arousal concerns reported by this group of women fit the criteria for Female Sexual Arousal Disorder (FSAD), defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revised (DSM-IV-TR) as "persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement" where "the disturbance causes marked distress or interpersonal difficulty" (American Psychiatric Association, 2000). A proportion of these women also experience new onset difficulties becoming subjectively sexually aroused, likely as a direct result of the genital arousal difficulties, but also due to the impact of cancer and hysterectomy on psychological function. Despite the wide prevalence of such subjective arousal concerns, this is not a diagnostic category in the DSM-IV-TR. However, the International Consultation on Sexual Dysfunctions, in collaboration with the World Health Organization, has suggested that "Subjective Sexual Arousal Disorder" be recognized as a valid concern (Basson et al., 2003). Evidence-based treatments for FSAD related to genital or subjective arousal difficulties do not exist, and persisting distress due to untreated sexual dysfunction can compromise mental and physical health. The contents of our psychoeducational intervention were based on:
- empirically supported techniques in other areas of female sexual dysfunction (e.g., sensate focus, challenging of maladaptive cognitions and sexual myths);
- discussions with gynecological oncologists at the University of Washington who are usually the first-line recipients of such sexual complaints; and
- pilot interviews conducted with 18 cervical and endometrial cancer survivors to date.
The intervention focuses primarily on sexual arousal, both genital and subjective, and secondarily on the interaction between cervical cancer and hysterectomy with relationship satisfaction, body image, and beliefs about health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cervical or endometrial cancer, in remission for at least 1 year
- Treatment by hysterectomy at least one year earlier
- Diagnosis of female sexual arousal disorder (FSAD) according to DSM-IV-TR criteria with new onset after the hysterectomy
- Currently involved in a relationship
Key exclusion criteria (6 listed)
- Treatment by either radiation or chemotherapy alone
- Current diagnosis of primary hypoactive sexual desire disorder - or in other words, if complaints of sexual desire are present, they must be less distressing than the sexual arousal complaints.
- Unstable psychopathology and Beck Depression Inventory scores greater than 19
- Lack of sexual experience
- Current use of antidepressants or other medication with known sexual side effects
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 |
|---|---|---|
| psychoeducational interventionthree 75 minute long individual psychoeducational sessions | Behavioural | – |
Primary outcome
Upon completion of data analysis, establishment of the efficacy of a psychoeducational intervention (PED) in a sample of cervical or endometrial cancer survivors with sexual arousal disorder will be determined.
Time frame: upon completion of data collection
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 2 Mar 2011.
- Background: PubMed 9842287Butler L, Banfield V, Sveinson T, Allen K. Conceptualizing sexual health in cancer care. West J Nurs Res. 1998 Dec;20(6):683-99; discussion 700-5. doi: 10.1177/019394599802000603.
- Background: PubMed 11839509Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical and simple hysterectomy: a quantitative study of nerve types in the uterine supporting ligaments. J Soc Gynecol Investig. 2002 Jan-Feb;9(1):47-56. doi: 10.1016/s1071-5576(01)00145-9.
- Background: PubMed 11737468Grumann M, Robertson R, Hacker NF, Sommer G. Sexual functioning in patients following radical hysterectomy for stage IB cancer of the cervix. Int J Gynecol Cancer. 2001 Sep-Oct;11(5):372-80. doi: 10.1046/j.1525-1438.2001.01051.x.
- Background: PubMed 12673810Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology. 2003 Apr-May;12(3):267-79. doi: 10.1002/pon.639.
- Background: PubMed 11240799Kylstra WA, Leenhouts GH, Everaerd W, Panneman MJ, Hahn DE, Weijmar Schultz WC, Van De Wiel HB, Heintz AP. Sexual outcomes following treatment for early stage gynecological cancer: a prospective multicenter study. Int J Gynecol Cancer. 1999 Sep;9(5):387-395. doi: 10.1046/j.1525-1438.1999.99052.x.
- Background: PubMed 10348277Robinson JW, Faris PD, Scott CB. Psychoeducational group increases vaginal dilation for younger women and reduces sexual fears for women of all ages with gynecological carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):497-506. doi: 10.1016/s0360-3016(99)00048-6.
- Background: PubMed 11921330Wenzel LB, Donnelly JP, Fowler JM, Habbal R, Taylor TH, Aziz N, Cella D. Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study. Psychooncology. 2002 Mar-Apr;11(2):142-53. doi: 10.1002/pon.567.
- Background: PubMed 9086685Andersen BL, Woods XA, Copeland LJ. Sexual self-schema and sexual morbidity among gynecologic cancer survivors. J Consult Clin Psychol. 1997 Apr;65(2):221-9. doi: 10.1037//0022-006x.65.2.221.
- Background: PubMed 3700803Anderson BJ, Wolf FM. Chronic physical illness and sexual behavior: psychological issues. J Consult Clin Psychol. 1986 Apr;54(2):168-75. doi: 10.1037//0022-006x.54.2.168. No abstract available.
- Background: PubMed 10951347Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000 Aug 15;89(4):834-41. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-7.
- Background: PubMed 7369850Capone MA, Good RS, Westie KS, Jacobson AF. Psychosocial rehabilitation of gynecologic oncology patients. Arch Phys Med Rehabil. 1980 Mar;61(3):128-32.
- Background: PubMed 12189897Leenhouts GH, Kylstra WA, Everaerd W, Hahn DE, Schultz WC, van de Wiel HB, Heintz AP. Sexual outcomes following treatment for early-stage gynecological cancer: a prospective and cross-sectional multi-center study. J Psychosom Obstet Gynaecol. 2002 Jun;23(2):123-32. doi: 10.3109/01674820209042794.
- primary investigator's websiteLink provided by the sponsor.
Related trials for Sexual Dysfunctions, Psychological
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
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.
Rosemary Basson, FCRP (UK) principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducational intervention in people with Sexual Dysfunctions, Psychological, run by University of British Columbia at 1 site in Canada.
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 6 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 2 Mar 2011. 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 Canada. 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.
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?
Upon completion of data analysis, establishment of the efficacy of a psychoeducational intervention (PED) in a sample of cervical or endometrial cancer survivors with sexual arousal disorder will be determined. (time frame: upon completion of data collection). 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 NCT00134316, which also lists 13 linked publications.
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 2 Mar 2011.