Breast CancerPhase 3NCT00607295
Efficacy and Safety of Clino-san on Vaginal Dryness of Breast Cancer Patients
A Phase 3 study testing clino-san vaginal lubricant in people with Breast Cancer and Vaginal Atrophy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life. 2. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer, Vaginal Atrophy
- What is being tested?
- clino-san vaginal lubricant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Feb 2009
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients
- who are treated with chemotherapy or hormonal therapy
- who experience no menstruation after the previous therapy
- who complain of vaginal dryness
Who cannot join
- other cancer patients
- other severe disease
- poor compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
- Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
- "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
- We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.
- Conditions
- Breast Cancer, Vaginal Atrophy
- Being tested
- clino-san vaginal lubricant
- Keywords
- chemotherapy, hormonal therapy, urogenital atrophy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clino-san vaginal lubricantDrug
Clino-san 2ml vaginal application 3 times per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Clino-san 2ml vaginal application 3 times per week for 12 weeks Receives: Drug: clino-san vaginal lubricant |
| 2 | Placebo comparator | placebo 2ml vaginal application 3 times per week for 12 weeks Receives: Drug: clino-san vaginal lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal dryness score
Measured: for 12 weeks
Secondary outcomes (1)
sexual dysfunction
Measured: for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jae Weon Kim, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607295
- Sponsor's protocol ID
- SNUH-OG-07-211
- Status last verified
- Jul 2010
- First submitted
- 4 Feb 2008
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee YK, Chung HH, Kim JW, Park NH, Song YS, Kang SB. Vaginal pH-balanced gel for the control of atrophic vaginitis among breast cancer survivors: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):922-927. doi: 10.1097/AOG.0b013e3182118790.
PubMed 21422866
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00607295
- Acronym / sponsor ID
- SNUH-OG-07-211
- Conditions
- Breast Cancer, Vaginal Atrophy
- Keywords
- chemotherapy, hormonal therapy, urogenital atrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Feb 2008 (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.
- Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
- "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
- We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clino-san vaginal lubricantClino-san 2ml vaginal application 3 times per week for 12 weeks |
| 2 | Placebo comparator | Drug: clino-san vaginal lubricantplacebo 2ml vaginal application 3 times per week for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- breast cancer patients
- who are treated with chemotherapy or hormonal therapy
- who experience no menstruation after the previous therapy
- who complain of vaginal dryness
Key exclusion criteria (3 listed)
- other cancer patients
- other severe disease
- poor compliance
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 |
|---|---|---|
| clino-san vaginal lubricantClino-san 2ml vaginal application 3 times per week for 12 weeks | Drug | 1, 2 |
Primary outcome
vaginal dryness score
Time frame: for 12 weeks
1 secondary outcome
sexual dysfunction
Time frame: for 12 weeks
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 27 Jul 2010.
- Derived from this study: PubMed 21422866Lee YK, Chung HH, Kim JW, Park NH, Song YS, Kang SB. Vaginal pH-balanced gel for the control of atrophic vaginitis among breast cancer survivors: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):922-927. doi: 10.1097/AOG.0b013e3182118790.
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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.
Jae Weon Kim, MD, PhD study director
Seoul National University Hospital
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 clino-san vaginal lubricant in people with Breast Cancer and Vaginal Atrophy, run by Seoul National University Hospital at 1 site in South Korea.
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 27 Jul 2010. 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 South Korea. 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?
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?
vaginal dryness score (time frame: for 12 weeks). 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 NCT00607295, which also lists 1 linked publication.
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 27 Jul 2010.